Title,Section,SourcePublication,"Page Number",PostDate,OfficialDate,PrintPublication,OnlinePublication,Description
"ONDANSETRON TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"In Table 1/footnotes: Change
b1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
c1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
d3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
e1,2,3,9-Tetrahydro-9-methyl-3-[1H-imidazol-1-yl)methyl]-4H-carbazol-4-one.
to:
b9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
c9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one.
d3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
e3-[(1H-Imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one."
"POWDERED VALERIAN EXTRACT",DEFINITION,"USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"Change
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid, on the dried basis.
to:
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid, on the anhydrous basis."
"PANTOPRAZOLE SODIUM","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"In USP Pantoprazole Related Compound E RS: Change
A mixture of the stereoisomers of 6,6′-bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazolyl.
to:
6,6′-Bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazole."
"CORN STARCH","IMPURITIES/Limit of Sulfur Dioxide","USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"In Bromophenol blue indicator solution: Change
0.2 mg/mL of bromophenol blue in dilute alcohol. Filter if necessary.
to:
Dissolve 100 mg of bromophenol blue in 100 mL of dilute alcohol (1 in 5), and filter if necessary."
"ONDANSETRON TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"Change
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
to:
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride."
"POWDERED VALERIAN EXTRACT","COMPOSITION/Content of Valerenic Acids","USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"In Acceptance criteria: Change
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the dried basis
to:
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the anhydrous basis"
"ONDANSETRON ORAL SOLUTION","USP Reference standards <11>","USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"Change
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
USP Ondansetron Related Compound C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
USP Ondansetron Related Compound D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
to:
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.
USP Ondansetron Related Compound C RS
9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one.
USP Ondansetron Related Compound D RS
9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one."
"ACYCLOVIR FOR INJECTION",IMPURITIES/Procedure,"USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"In Standard solution A: Change
0.5 μg/mL of Acyclovir standard solution in Solution A
to:
0.5 μg/mL of USP Acyclovir RS from Acyclovir standard solution in Solution A
AND
In Standard solution B: Change
5 μg/mL of Guanine solution in Solution A
to:
5 μg/mL of guanine from Guanine solution in Solution A
AND
In Analysis 1: Change
rS = peak response of guanine in the Standard solution
CS = concentration of guanine in the Standard solution
to:
rS = peak response of guanine in Standard solution B
CS = concentration of guanine in Standard solution B
AND
In Analysis 2: Change
rS = peak response of acyclovir in the Standard solution
CS = concentration of USP Acyclovir RS in the Standard solution (mg/mL)
to:
rS = peak response of acyclovir in Standard solution A
CS = concentration of USP Acyclovir RS in Standard solution A (mg/mL)"
"DIBASIC POTASSIUM PHOSPHATE",ASSAY/Procedure,"USPNF Online",Online,25-Mar-2022,1-Apr-2022,NA,NA,"In Analysis: Change
Titrate the Blank with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution with 1 N sodium hydroxide VS to the inflection point at pH 4, and record the buret reading.
to:
Titrate the Blank potentiometrically with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution potentiometrically with 1 N sodium hydroxide VS to the inflection point at pH 4, and record the buret reading."
"MECAMYLAMINE HYDROCHLORIDE","USP Reference standards <11>","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"In USP Mecamylamine Related Compound A RS: Change
N,1,7,7-Tetramethyl bicyclo [2.2.1]heptan-2-amine.
C11H21N 167.29
to:
N,1,7,7-Tetramethylbicyclo[2.2.1]heptan-2-amine hydrochloride.
C11H21N · HCl 203.75"
"MUPIROCIN CALCIUM","CHEMICAL INFORMATION","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,Change
1075.34
to:
1075.35
"MUPIROCIN CREAM","Related compounds/Table 1","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid."
"BROMOCRIPTINE MESYLATE CAPSULES","PERFORMANCE TESTS/Dissolution <711>","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"In Analysis: Change
bromocriptine mesylate (C32H40BrN5O5 · CH4SO3)
to:
bromocriptine (C32H40BrN5O5)
AND
In Tolerances: Change
bromocriptine mesylate (C32H40BrN5O5 · CH4SO3)
to:
bromocriptine (C32H40BrN5O5)"
"DACARBAZINE FOR INJECTION",IDENTIFICATION,"USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"Delete
Identification test C"
"MUPIROCIN CALCIUM","IMPURITIES/Organic Impurities/Table 1","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid."
"MUPIROCIN NASAL OINTMENT","Related compounds/Table 1","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid."
"DACARBAZINE FOR INJECTION",IMPURITIES,"USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"Delete
Limit of 2-Azahypoxanthine test"
"MUPIROCIN OINTMENT","IMPURITIES/Organic Impurities/Table 2","USPNF Online",Online,29-Apr-2022,1-May-2022,NA,NA,"In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:
9-{(E)-4-[(2R,3aS,6S,7S)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid."
"APREPITANT CAPSULES","PERFORMANCE TESTS/Dissolution <711>","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"Change
Test 1 Dilute 1 mL of phosphoric acid with water to 1 L.
to:
Test 1
AND
Change
Dilute phosphoric acid:
to:
Dilute phosphoric acid: Dilute 1 mL of phosphoric acid with water to 1 L."
"DOXYCYCLINE HYCLATE","IMPURITIES/Organic Impurities","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,11(4H,5H)-dione."
"DIMENHYDRINATE TABLETS","OTHER COMPONENTS/8-Chlorotheophylline","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In Analysis: Change
CU = nominal concentration of dimenhydrinate in the Sample solution (mg/mL)
to:
CU = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay (mg/mL)"
"AZITHROMYCIN FOR ORAL SUSPENSION","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In USP Azithromycin Related Compound F RS: Change
762.97
to:
762.98
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80"
"ATRACURIUM BESYLATE","CHEMICAL INFORMATION","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"Change
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
to:
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester"
"CARBAMAZEPINE TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In USP Carbamazepine Related Compound A RS: Change
238.28
to:
238.29
AND
In USP Carbamazepine Related Compound B RS: Change
193.24
to:
193.25
AND
In USP 9-Methylacridine RS: Change
193.24
to:
193.25"
"<565> BOTANICAL EXTRACTS",PREPARATIONS,"USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)
to:
where L is the limit in the original article as listed in Table 5 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)"
"DOXYCYCLINE HYCLATE","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
480.13
to:
480.90"
RIFABUTIN,"CHEMICAL INFORMATION","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"Change
847.00
to:
847.02
AND
Change
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate
to:
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,18,20-Trihydroxy-1’-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-5,10,26-trioxo-3,5,9,10-tetrahydrospiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2’,3’:7,8]naphtho[1,2-d]imidazole-2,4’-piperidin]-16-yl acetate"
"DOXYCYCLINE HYCLATE","CHEMICAL INFORMATION","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,Change
1025.87
to:
1025.88
"FLUOCINOLONE ACETONIDE","Organic Impurities","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In Acceptance criteria/Total impurities: Change
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Standard solution.
to:
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Sample solution."
"NANDROLONE DECANOATE",ASSAY/Procedure,"USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In Analysis: Change
Calculate the percentage of Nandrolone Decanoate (C28H44O3) in the portion of Nandrolone Decanoate taken:
to:
Calculate the percentage of nandrolone decanoate (C28H44O3) in the portion of Nandrolone Decanoate taken:"
"IBUPROFEN ORAL SUSPENSION","PERFORMANCE TESTS/Dissolution <711>","USPNF Online",Online,27-May-2022,1-Jun-2022,NA,NA,"In Analysis: Change
Result = (RU/RS) x CS x V x (D/WU) x (1/L) x 100
RU = peak area ratio of ibuprofen to benzophenone from the Sample solution
RS = peak area ratio of ibuprofen to benzophenone from the Standard solution
CS = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
D = density of Oral Suspension (g/mL)
WU = weight of the portion of Oral Suspension added to the Medium (g)
L = label claim (mg/mL)
to:
Result = (RU/RS) x CS x V x (d/WU) x D x (1/L) x 100
RU = peak area ratio of ibuprofen to benzophenone from the Sample solution
RS = peak area ratio of ibuprofen to benzophenone from the Standard solution
CS = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
d = density of Oral Suspension (g/mL)
WU = weight of the portion of Oral Suspension added to the Medium (g)
D = dilution factor of the Sample solution, 2
L = label claim (mg/mL)"
"AMMONIUM GLYCYRRHIZATE","ASSAY/Content of Ammonium 18α- and 18β-Glycyrrhizate","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In Analysis: Change
MW(Salt) = molecular weight of ammonium glycyrrhizate, 840.08 g/mol
MW(Acid) = molecular weight of glycyrrhizic acid, 821.59 g/mol
to:
MW(Salt) = molecular weight of ammonium glycyrrhizate, 839.97 g/mol
MW(Acid) = molecular weight of glycyrrhizic acid, 822.94 g/mol"
"MELENGESTROL ACETATE","USP Reference standards 〈11〉","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Melengestrol Acetate Related Compound A RS: Change
16-Methylene-17α-hydroxy-4-pregnene-3,20-dione 17-acetate.
to:
16-Methylene-3,20-dioxopregn-4-en-17-yl acetate.
AND
In USP Melengestrol Acetate Related Compound B RS: Change
17α-Hydroxy-6,16-dimethyleneprogna-4-ene-3,20-dione 17-acetate.
to:
6,16-Dimethylene-3,20-dioxopregn-4-en-17-yl acetate."
"DOXYCYCLINE CAPSULES","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.
C22H24N2O8 · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C22H24N2O8 · HCl 480.90"
"DOXYCYCLINE HYCLATE TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C22H24N2O8 · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C22H24N2O8 · HCl 480.90"
"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS","IMPURITIES/Limit of Homatropine Hydrobromide and Related Substances","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In Buffer: Change
Adjust with phosphoric acid to a pH of 6.4 ± 0.01.
to:
Adjust with phosphoric acid to a pH of 6.4 ± 0.1."
"HOMATROPINE HYDROBROMIDE","CHEMICAL INFORMATION","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"Change
356.25
to:
356.26
AND
Change
1αH,5αH-Tropan-3α-ol mandelate (ester) hydrobromide
to:
(1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2-phenylacetate hydrobromide"
"DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C22H24N2O8 · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C22H24N2O8 · HCl 480.90"
"AMMONIUM GLYCYRRHIZATE","SPECIFIC TESTS","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In Optical Rotation, Specific Rotation 〈781〉: Change
〈781〉
to:
〈781S〉
AND
Change
Acceptance criteria: +49.0 to +55.0 on the anhydrous basis
to:
Acceptance criteria: +49.0° to +55.0° on the anhydrous basis"
METHOTREXATE,"ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Methotrexate System Suitability Mixture RS: Change
C22H26N8O5 · HCl 518.95
to:
C22H26N8O5 · xHCl"
"DOXYCYCLINE FOR INJECTION","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C22H24N2O8 · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C22H24N2O8 · HCl 480.90"
"ASCORBIC ACID INJECTION",ASSAY/Procedure,"USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In Chromatographic system/Column: Change
150-cm × 6-mm; packing L39
to:
15-cm × 6-mm; packing L39"
"AMMONIUM GLYCYRRHIZATE","CHEMICAL INFORMATION","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"Change
840.08
to:
839.97"
"MELENGESTROL ACETATE","CHEMICAL INFORMATION","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,Change
396.52
to:
396.53
IVERMECTIN,"CHEMICAL INFORMATION","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"Change
C48H74O14(Component H2B1a) 875.09
C47H72O14(Component H2B1b) 861.07
Component H2B1a:
Avermectin A1a, 5-O-demethyl-22,23-dihydro-.
(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6′-(S)-sec-Butyl-3′,4′,5′,6,6′,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70161-11-4.
Component H2B1b:
Avermectin A1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-.
(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3′,4′,5′,6,6′,7,10,11,-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU.
to:
C48H74O14(Component H2B1a) 875.11
C47H72O14(Component H2B1b) 861.08
Component H2B1a:
Avermectin A1a, 5-O-demethyl-22,23-dihydro-.
(2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-6’-(S)-sec-Butyl-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-tetradecahydro-20,20b-dihydroxy-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 71827-03-7; UNII: 91Y2202OUW.
Component H2B1b:
Avermectin A1a, 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)-.
(2aE,4E,8E)-(5’S,6S,6’R,7S,11R,13R,15S,17aR,20R,20aR,20bS)-3’,4’,5’,6,6’,7,10,11,14,15,17a,20,20a,20b-Tetradecahydro-20,20b-dihydroxy-6’-isopropyl-5’,6,8,19-tetramethyl-17-oxospiro [11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2’-[2H]pyran]-7-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside CAS RN®: 70209-81-3; UNII: 0W28CYI3TU."
"DOXYCYCLINE HYCLATE CAPSULES","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C22H24N2O8 · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C22H24N2O8 · HCl 480.90"
"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS",ASSAY/Procedure,"USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In Buffer: Change
Adjust with phosphoric acid to a pH of 6.4 ± 0.01.
to:
Adjust with phosphoric acid to a pH of 6.4 ± 0.1."
"NONOXYNOL 9","CHEMICAL INFORMATION","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"Update the chemical structure
AND
Change
α-(p-Nonylphenyl)-ω-hydroxynona(oxyethylene)
CAS RN®: 26027-38-3.
to:
α-(4-Nonylphenyl)-ω-hydroxynona(oxyethylene)."
TRYPTOPHAN,"ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Tryptophan Related Compound A RS: Change
3,3′-[Ethylidenebis(1H-indole-1,3-diyl)]bis[2S)-2-aminopropanoic]acid.
C24H26N4O4 432.49
to:
(2S,2'S)-3,3'-[Ethane-1,1-diylbis(1H-indole-1,3-diyl)]bis(2-aminopropanoic acid).
C24H26N4O4 434.50"
"DOXYCYCLINE TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,24-Jun-2022,1-Jul-2022,NA,NA,"In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide, monohydrochloride.
C22H24N2O8 · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C22H24N2O8 · HCl 480.90"
"MILK THISTLE CAPSULES","PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution","USPNF Online",Online,24-Jun-2022,1-Aug-2022,NA,NA,"In Medium: Change
Buffer containing 2% lauryl sulfate; 900 mL
to:
Buffer containing 2% sodium lauryl sulfate; 900 mL"
"<871> SUTURES--NEEDLE ATTACHMENT",PROCEDURE,"USPNF Online",Online,29-Jul-2022,1-Aug-2022,NA,NA,"In Removable Needle Attachment: Change
For USP sizes 5-0 through 2-0,
to:
For USP sizes 5-0 through 2,"
"BACLOFEN INJECTION","SPECIFIC TESTS","USPNF Online",Online,29-Jul-2022,1-Aug-2022,NA,NA,"Change
• Osmolality and Osmolarity 〈785〉, Osmolality: 270–320 mOsm/kg
to:
• Osmolality and Osmolarity 〈785〉
Osmolality: 270–320 mOsm/kg"
"POWDERED FORSKOHLII","COMPOSITION/Content of Forskolin","USPNF Online",Online,29-Jul-2022,1-Aug-2022,NA,NA,"In Chromatographic system: Change
Column: 4.6-mm × 25-cm; 5-µm, 100 Å
to:
Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1"
"MILK THISTLE TABLETS","PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution","USPNF Online",Online,24-Jun-2022,1-Aug-2022,NA,NA,"In Medium: Change
Buffer containing 2% lauryl sulfate; 900 mL
to:
Buffer containing 2% sodium lauryl sulfate; 900 mL"
"POWDERED FORSKOHLII EXTRACT","COMPOSITION/Content of Forskolin","USPNF Online",Online,29-Jul-2022,1-Aug-2022,NA,NA,"In Chromatographic system: Change
Column: 4.6-mm × 25-cm; 5-µm, 100 Å
to:
Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1"
"MELOXICAM ORAL SUSPENSION","PERFORMANCE TESTS/Dissolution <711>","USPNF Online",Online,29-Jul-2022,1-Aug-2022,NA,NA,"In Analysis: Change
WU = weight of the Oral Suspension taken (mg)
to:
WU = weight of the Oral Suspension taken (g)"
FORSKOHLII,"COMPOSITION/Content of Forskolin","USPNF Online",Online,29-Jul-2022,1-Aug-2022,NA,NA,"In Chromatographic system: Change
Column: 4.6-mm × 25-cm; 5-µm, 100 Å
to:
Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1"
"METHYLENE BLUE","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,"USPNF 2023 Issue 2","In USP Azure B RS: Change
3-(Dimethylamino)-7-(methylamino)-phenothiazine-5-ium chloride.
to:
3-(Dimethylamino)-7-(methylamino)phenothiazin-5-ium chloride."
METHSUXIMIDE,"IMPURITIES/Organic Impurities","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"In System suitability/Column efficiency: Change
NTL 5800 theoretical plates
to:
NLT 5800 theoretical plates"
"PROCHLORPERAZINE MALEATE TABLETS","PERFORMANCE TESTS/Dissolution <711>","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"In Analysis: Change
Results = (AU/AS) × CS × D × (1/L) × V × 100
AU = absorbance of the Sample solution
AS = absorbance of the Standard solution
CS = concentration of USP Prochlorperazine Maleate RS in the Standard solution
D = dilution factor for Sample solution, if needed
L = label claim (mg/Tablet)
V = volume of Medium, 500 mL
to:
Result = (AU/AS) × CS × V × D × (Mr1/Mr2) × (1/L) × 100
AU = absorbance of the Sample solution
AS = absorbance of the Standard solution
CS = concentration of USP Prochlorperazine Maleate RS in the Standard solution
V = volume of Medium, 500 mL
D = dilution factor for the Sample solution, if needed
Mr1 = molecular weight of prochlorperazine, 373.94
Mr2 = molecular weight of prochlorperazine maleate, 606.09
L = label claim (mg/Tablet)"
"<467> RESIDUAL SOLVENTS","USP REFERENCE STANDARDS <11>","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"Change
USP Residual Solvent Class 2—Mixture C RS
to:
USP Residual Solvents Class 2—Mixture C RS"
"IRINOTECAN HYDROCHLORIDE INJECTION",DEFINITION,"USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"Change
NTL 90.0% and NMT 110.0%
to:
NLT 90.0% and NMT 110.0%"
"ECONAZOLE NITRATE","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,"USPNF 2023 Issue 2","In USP Econazole Related Compound C RS: Change
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium nitrate (salt).
C25H21Cl14N3O4 569.26
to:
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium chloride.
C25H21Cl5N2O 542.71"
"PROMETHAZINE HYDROCHLORIDE","IMPURITIES/Organic Impurities","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent"
"METHYLENE BLUE","IMPURITIES/Organic Impurities","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,"USPNF 2023 Issue 2","In footnote a in Table 2: Change
3-(Dimethylamino)-7-(methylamino)-phenothiazine-5-ium chloride.
to:
3-(Dimethylamino)-7-(methylamino)phenothiazin-5-ium chloride."
"POTASSIUM GLUCONATE","IMPURITIES/Reducing Substances","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"In Titrimetric system: Change
Titrant: Iodine
Back-titrant: Sodium thiosulfate
to:
Titrant: 0.1 N Iodine VS
Back-titrant: 0.1 N Sodium Thiosulfate VS"
"0.1 N Potassium Permanganate VS",STANDARDIZATION,"USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"In Standardization with potentiometric endpoint: Change
N = g Na2C2O4/mL KMNnO4 solution × 0.06700
to:
N = g Na2C2O4/mL KMnO4 solution × 0.06700"
"DACARBAZINE FOR INJECTION","IMPURITIES/Organic Impurities","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"In System suitability/Suitability requirements/Signal-to-noise ratio: Change
NTL 10,
to:
NLT 10,"
"PROMETHAZINE HYDROCHLORIDE TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,26-Aug-2022,1-Sep-2022,NA,NA,"Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent"
"LANSOPRAZOLE DELAYED-RELEASE CAPSULES","IMPURITIES/Organic Impurities","USPNF Online",Online,30-Sep-2022,1-Oct-2022,NA,NA,"Delete
Blank: Methanol and Diluent (1:9)"
"TERAZOSIN CAPSULES",ASSAY/Procedure,"USPNF Online",Online,30-Sep-2022,1-Oct-2022,NA,NA,"In Hydrochloric acid solution: Change
0.1 N methanolic hydrochloric acid
to:
0.01 N methanolic hydrochloric acid"
"CEFTIOFUR HYDROCHLORIDE",ASSAY/Procedure,"USPNF Online",Online,30-Sep-2022,1-Oct-2022,NA,NA,"In Analysis: Change
Calculate the percentage of ceftiofur (C19H17N5O7S3) in the portion of Ceftiofur Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × P × 100
to:
Calculate the quantity, in µg/mg, of ceftiofur (C19H17N5O7S3) in the portion of Ceftiofur Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × P"
"SODIUM PICOSULFATE","IMPURITIES/Organic Impurities","USPNF Online",Online,30-Sep-2022,1-Oct-2022,NA,NA,"In Buffer: Change
cetylrimethylammonium bromide,
to:
cetyltrimethylammonium bromide,"
"CALCIUM L-5-METHYLTETRAHYDROFOLATE","IMPURITIES/Enantiomeric Purity","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS"
"DOXORUBICIN HYDROCHLORIDE FOR INJECTION",ASSAY/Procedure,"USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)"
ANETHOLE,DEFINITION,"USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"Change
(E)-1-methyl-4-(1-propenyl) benzene
to:
(E)-1-methoxy-4-(1-propenyl) benzene"
"CALCIUM L-5-METHYLTETRAHYDROFOLATE",ASSAY/Procedure,"USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In System suitability solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In System suitability/Samples: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Analysis: Change
CS = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
CS = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)"
"TETRACYCLINE HYDROCHLORIDE","ADDITIONAL REQUIREMENTS/Labeling","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled."
"DOXORUBICIN HYDROCHLORIDE INJECTION","IMPURITIES/Organic Impurities","USPNF 2022 Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)"
"DOXAZOSIN MESYLATE","IMPURITIES/Organic Impurities","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Analysis: Change
CS = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
CS = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)"
"CALCIUM L-5-METHYLTETRAHYDROFOLATE","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS"
"DOXORUBICIN HYDROCHLORIDE FOR INJECTION","IMPURITIES/Organic Impurities","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)"
"CALCIUM L-5-METHYLTETRAHYDROFOLATE","IMPURITIES/Related Compounds","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Analysis: Change
CS = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
CS = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)"
"SITAGLIPTIN PHOSPHATE","CHEMICAL INFORMATION","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"Change
523.32
to:
523.33
AND
Change
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
to:
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate"
DOFETILIDE,"CHEMICAL INFORMATION","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"Change
β-[(p-Methanesulfonamidophenethyl)methylamino]methane sulfono-p-phenetidide
to:
N-{4-[2-(Methyl{2-[4-(methylsulfonamido)phenoxy]ethyl}amino)ethyl]phenyl}methanesulfonamide"
"CALCIUM UNDECYLENATE",ASSAY/Procedure,"USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid VS to a 500-mL volumetric flask, dilute with water to volume, and mix well."
"CALCIUM L-5-METHYLTETRAHYDROFOLATE",IDENTIFICATION,"USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In A. Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS"
"TETRACYCLINE HYDROCHLORIDE","SPECIFIC TESTS/Bacterial Endotoxins Test <85>","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which tetracycline hydrochloride is used can be met.
to:
Where the label states Tetracycline Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Tetracycline Hydrochloride is used can be met."
"DOXORUBICIN HYDROCHLORIDE INJECTION",ASSAY/Procedure,"USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)"
DIAZOXIDE,"IMPURITIES/Organic Impurities","USPNF Online",Online,28-Oct-2022,1-Nov-2022,NA,NA,"In footnote a in Table 2: Change
7-Chloro-2H-benzothiadiazin-3(4H)-one 1,1-dioxide.
to:
7-Chloro-2H-1,2,4-benzothiadiazin-3(4H)-one 1,1-dioxide.
"
"PENICILLIN G BENZATHINE INJECTABLE SUSPENSION",IDENTIFICATION,"USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension.
to:
Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in RF value to that obtained from the Standard solution."
"<621> CHROMATOGRAPHY","ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS","USPNF Online",Online,29-Apr-2022,1-Dec-2022,NA,NA,"In Liquid Chromatography: Isocratic Elution/Injection volume: Change
Result = (Vinj2 = Vinj1 (L2 dc22 )/(L1 dc12)
to:
Vinj2 = Vinj1 (L2 dc22 )/(L1 dc12)
AND
In Liquid Chromatography: Gradient Elution/Column parameters and flow rate: Change
F2 = F2 × [(dc22 × dp1)/(dc12 × dp2)]
to:
F2 = F1 × [(dc22 × dp1)/(dc12 × dp2)]"
"PRIMIDONE TABLETS",ASSAY/Procedure,"USPNF Online",Online,28-Oct-2022,1-Dec-2022,NA,NA,"In Sample solution: Change
0.05 mg/mL of primidone from the Standard stock solution in Diluent
to:
0.05 mg/mL of primidone from the Sample stock solution in Diluent"
"ADIPIC ACID","IMPURITIES/Related Substances","USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"In Table 2: Change
Pimelic acid 1.21 0.91
Valeric acid 1.21 0.91
to:
Pimelic acid 1.21 0.91
Valeric acid 1.46 0.88"
"ROCURONIUM BROMIDE","CHEMICAL INFORMATION","USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,"USPNF 2023 Issue 3",Change
609.68
to:
609.69
"0.1 M ZINC SULFATE VS",STANDARDIZATION,"USPNF Online",Online,26-Aug-2022,1-Dec-2022,NA,NA,"In Standardization with visual end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO4
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO4
AND
In Standardization with potentiometric end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO4
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO4"
"ZINC UNDECYLENATE",ASSAY/Procedure,"USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of 0.5 N hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well."
"PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE SUSPENSION",IDENTIFICATION,"USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"In Test A: Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.
to:
Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in RF value to that obtained from the Standard solution. The spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine."
"MAGNESIUM OXIDE","IMPURITIES/Limit of Calcium","USPNF Online",Online,25-Feb-2022,1-Dec-2022,NA,NA,"In Analysis: Change
CU = concentration of Magnesium Hydroxide in the Sample solution (mg/mL)
to:
CU = concentration of Magnesium Oxide in the Sample solution (mg/mL)"
"<621> CHROMATOGRAPHY","ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS","USPNF Online",Online,26-Aug-2022,1-Dec-2022,NA,NA,"In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L2 = internal diameter of the column used (mm)
dc1 = particle size indicated in the monograph (µm)
dc2 = particle size of the column used (µm)
to:
L2 = new column length (mm)
dc1 = column internal diameter indicated in the monograph (mm)
dc2 = new column internal diameter (mm)"
ENZACAMENE,ASSAY/Procedure,"USPNF Online",Online,28-Oct-2022,1-Dec-2022,NA,NA,"In Analysis: Change
CU = concentration of enzacamene in the Sample solution (mg/mL)
to:
CU = concentration of Enzacamene in the Sample solution (mg/mL)"
"NALOXONE HYDROCHLORIDE",IMPURITIES,"USPNF Online",Online,28-Oct-2022,1-Dec-2022,NA,NA,"In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution"
"POTASSIUM CITRATE EXTENDED-RELEASE TABLETS","PERFORMANCE TESTS/Dissolution <711>","USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"In Test 6: Change
Times: 0.5, 1, and 4 h—for strengths 540 and 1080 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strength 1620 mg as potassium citrate monohydrate.
to:
Times: 0.5, 1, and 4 h—for strength 540 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strengths 1080 and 1620 mg as potassium citrate monohydrate."
"N-Benzoyl-L-arginine Ethyl Ester Hydrochloride","REAGENT SPECIFICATIONS","USPNF Online",Online,30-Sep-2022,1-Dec-2022,NA,NA,"Change
Crystallized Trypsin (USP Monograph).
to:
Trypsin (USP Monograph)."
"ROCURONIUM BROMIDE","IMPURITIES/Organic Impurities","USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,"USPNF 2023 Issue 3","In footnote b of Table 1: Change
2β-(Morpholin-4-yl)-16β-(pyrrolidin-1-yl)-5α-androstan-3α,17β-diol.
to:
2β-(Morpholin-4-yl)-16β-(pyrrolidin-1-yl)-5α-androstane-3α,17β-diol."
LATANOPROST,ASSAY/Procedure,"USPNF Online",Online,29-Jul-2022,1-Dec-2022,NA,NA,"Change
Standard solution: Transfer 2.0 mg/mL of USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution: Transfer 2.0 mg/mL of Latanoprost into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
to:
Standard solution: 2.0 mg/mL of USP Latanoprost RS prepared as follows. Transfer USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution: 2.0 mg/mL of Latanoprost prepared as follows. Transfer Latanoprost into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume."
"CHLORHEXIDINE GLUCONATE ORAL RINSE","IMPURITIES/Limit of p-Chloroaniline","USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"Change
Standard solution: 1.0 µg/mL of USP p-Chloroaniline RS in Diluent
to:
Standard solution: 0.001 mg/mL of USP p-Chloroaniline RS in Diluent
AND
In Analysis: Change
Result = (rU/rS) × (CS/CU) × D × 100
to:
Result = (rU/rS) × (CS/CU) × 100
AND
Delete
D = dilution factor for the Sample solution, 2.5"
"MOMETASONE FUROATE TOPICAL SOLUTION",IDENTIFICATION,"USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"In test A: Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay.
to:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay."
"<621> CHROMATOGRAPHY","SYSTEM SUITABILITY","USPNF Online",Online,25-Mar-2022,1-Dec-2022,NA,NA,"Change
System Repeatability—Assay of an Active Substance or an Excipient
to:
System Repeatability"
FELODIPINE,"IMPURITIES/Organic Impurities","USPNF Online",Online,18-Nov-2022,1-Dec-2022,NA,NA,"Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay, and use 40 µL injection volume for the Sensitivity solution."
"MAFENIDE ACETATE FOR TOPICAL SOLUTION","IMPURITIES/Organic Impurities","USPNF Online",Online,16-Dec-2022,1-Jan-2023,NA,NA,"In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
AND
In Analysis: Change
Samples: Mobile phase, Standard solution A, and Sample solution
Chromatograph the Standard solution and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.
to:
Samples: Mobile phase, Standard solution A, Standard solution B, and Sample solution
Chromatograph Standard solution B and adjust the integration parameters so that the response is 5%–15% of full-scale deflection."
"PALONOSETRON HYDROCHLORIDE",IMPURITIES,"USPNF Online",Online,16-Dec-2022,1-Jan-2023,NA,NA,"In Limit of Unspecified Impurities: Change
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Standard stock solution, and Chromatographic system: Proceed as directed in the Assay."
"METOLAZONE TABLETS",ASSAY/Procedure,"USPNF Online",Online,16-Dec-2022,1-Jan-2023,NA,NA,"In Buffer: Change
1.38 g of monobasic potassium phosphate monohydrate in 900 mL of water.
to:
1.38 g of monobasic sodium phosphate in 900 mL of water."
"MESO-ZEAXANTHIN PREPARATION",IDENTIFICATION/C.,"USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin"
"POTASSIUM GLUCONATE ORAL SOLUTION","SPECIFIC TESTS","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"Change
Alcohol Determination 〈611〉, Method II—Distillation Method:
to:
Alcohol Determination 〈611〉, Method I—Distillation Method:"
"Methyl Acetate","CHEMICAL INFORMATION","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"Change
CAS RN®: 74-20-9.
to:
CAS RN®: 79-20-9."
"AZTEC MARIGOLD ZEAXANTHIN EXTRACT","COMPOSITION/Procedure 4: Stereoisomeric Composition","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In System suitability/Suitability requirements/Resolution: Change
(3R,3′S meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Acceptance criteria: Change
(3R,3′S meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin"
"ISOBUTYL ALCOHOL",ASSAY/Procedure,"USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In Analysis: Change
rS = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
rT = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution"
"FLUTICASONE PROPIONATE NASAL SPRAY","IMPURITIES/Organic Impurities","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In Analysis: Change
Samples: System suitability solution, Identification solution, and Sample solution
to:
Samples: Identification solution and Sample solution"
"MESO-ZEAXANTHIN PREPARATION","COMPOSITION/Stereoisomeric Composition","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
to:
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
AND
In System suitability/Suitability requirements/Resolution: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Acceptance criteria: Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin"
"METARAMINOL BITARTRATE","SPECIFIC TESTS/Content of Tartaric Acid","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In Analysis: Change
Result = {[(VS−VB) × N × F]/2 × W} × 100
to:
Result = {[(VS−VB) × N × F]/(2 × W)} × 100"
"CHLOROPROCAINE HYDROCHLORIDE INJECTION",ASSAY/Procedure,"USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In Sample solution: Change
Transfer about 100 mg of chloroprocaine hydrochloride to a 100-mL volumetric flask, dissolve in 40 mL of methanol, and dilute with water to volume.
to:
Transfer a volume of Injection, equivalent to about 100 mg of chloroprocaine hydrochloride to a 100-mL volumetric flask, add 40 mL of methanol, and dilute with water to volume."
"POLYETHYLENE GLYCOL STANDARDS WITH MOLECULAR WEIGHTS OF 1000, 2000, 3000, 4000, AND 6000 DALTONS (G/MOL)","CHEMICAL INFORMATION","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"Change
CAS RN®: 25332-68-3.
to:
CAS RN®: 25322-68-3."
"DEXAMETHASONE SODIUM PHOSPHATE INJECTION",ASSAY/Procedure,"USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr22) × 100
to:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100"
"MESO-ZEAXANTHIN PREPARATION","ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In USP meso-Zeaxanthin RS: Change
(3R,3′S-meso)-Zeaxanthin.
to:
(3R,3′S)-Zeaxanthin."
"AZTEC MARIGOLD ZEAXANTHIN EXTRACT",IDENTIFICATION/C.,"USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"Change
(3R,3′S meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin"
"METARAMINOL BITARTRATE","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,27-Jan-2023,1-Feb-2023,NA,NA,"In USP Metaraminol Enantiomer RS: Change
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol.
C9H13NO2 167.21
to:
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol D-tartrate.
C9H13NO2 ∙ C4H6O6 317.29"
"METAPROTERENOL SULFATE ORAL SOLUTION",Identification/A.,"USPNF Online",Online,24-Feb-2023,1-Mar-2023,NA,NA,"Change
Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”:
to:
Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:"
"SOTALOL HYDROCHLORIDE","IMPURITIES/Organic Impurities","USPNF Online",Online,24-Feb-2023,1-Mar-2023,NA,NA,"In Analysis: Change
Calculate the percentage of any unspecified impurities in the portion of Sotalol Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU= sum of all the peak responses of all unspecified impurities from the Sample solution
to:
Calculate the percentage of any unspecified impurity in the portion of Sotalol Hydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response of each unspecified impurity from the Sample solution
AND
In Table 1: Change
Any unspecified impurities
to:
Any unspecified impurity"
"LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION","Assay for lidocaine hydrochloride","USPNF Online",Online,24-Feb-2023,1-Mar-2023,NA,NA,"Change
Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine and Epinephrine Injection.
to:
Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine Hydrochloride and Epinephrine Injection."
"METAPROTERENOL SULFATE TABLETS",Identification/A.,"USPNF Online",Online,24-Feb-2023,1-Mar-2023,NA,NA,"Change
Proceed as directed in Identification test A under Metaproterenol Sulfate Inhalation Solution, beginning with “Allow the spots to dry”:
to:
Allow the spots to dry, and develop the chromatogram in a solvent system consisting of the upper layer of a freshly prepared mixture of butyl alcohol, water, and formic acid (50:25:7) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light:"
"MIRTAZAPINE TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,24-Feb-2023,1-Mar-2023,NA,NA,"In System suitability/Suitability requirements/Resolution: Change
10-ketomirtazpine
to:
10-ketomirtazapine
AND
In Table 1: Change
1-Ketomirtazpinec
to:
1-Ketomirtazapinec"
"ERYTHROMYCIN DELAYED-RELEASE TABLETS","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Test 1: Change
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions)
to:
Buffer stage
Medium: 0.05 M pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL"
"CALCIUM LACTATE","CHEMICAL INFORMATION","USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"Change
Calcium lactate (1:2) hydrate
to:
Calcium lactate hydrate
AND
Change
Calcium lactate (1:2) pentahydrate
to:
Calcium lactate pentahydrate"
THYROID,ASSAY/Procedure,"USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Chromatographic system: Change
Column: 4.6-cm × 25-cm; packing L1
to:
Column: 4.6-mm × 25-cm; packing L1"
"PRAZOSIN HYDROCHLORIDE CAPSULES",ASSAY/Procedure,"USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Analysis: Change
CS = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
CU = nominal concentration of prazosin in the Sample solution (µg/mL)
Mr1 = molecular weight of prazosin, 383.41
Mr2 = molecular weight of prazosin hydrochloride, 419.86
to:
CS = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
CU = nominal concentration of prazosin in the Sample solution (mg/mL)
Mr1 = molecular weight of prazosin, 383.41
Mr2 = molecular weight of prazosin hydrochloride, 419.87"
"ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS","IMPURITIES/Limit of 2-Methylbenzhydrol","USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Standard solution: Change
7.5 µg/mL of USP 2-Methylbenzhydrol RS in methanol
to:
7.5 µg/mL of USP Methylbenzhydrol RS in methanol
AND
In Analysis: Change
CS = concentration of USP 2-Methylbenzhydrol RS in the Standard solution (mg/mL)
to:
CS = concentration of USP Methylbenzhydrol RS in the Standard solution (mg/mL)"
"ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION",Identification,"USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"Change
Proceed as directed in the Identification test under Erythromycin Ethylsuccinate Oral Suspension, beginning with “Prepare a Standard solution.”
to:
Prepare a Standard solution of USP Erythromycin Ethylsuccinate RS in methanol containing about 3 mg per mL. Apply separately 10 µL each of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel mixture, and allow to dry. Place the plate in an unlined chromatographic chamber, and develop the chromatograms in a solvent system consisting of a mixture of methanol and chloroform (85:15) until the solvent front has moved about 9 cm. Remove the plate from the chamber, mark the solvent front, and allow the solvent to evaporate. Spray the plate with a mixture of dehydrated alcohol, p-methoxybenzaldehyde, and sulfuric acid (90:5:5). Heat the plate at 100° for 10 minutes, and examine the chromatograms, in which the erythromycin and succinic acid moieties appear as black-to-purple spots: the RF values of the principal spots obtained from the test solution correspond to those obtained from the Standard solution."
"<209> LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS",PROCEDURE,"USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In footnote 1 in Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography/Chromatographic system/Columns/Analytical: Change
guard column TSK SWXL 6-mm × 4-mm;
to:
guard column TSK SWXL 6-mm × 4-cm;"
"THYROID TABLETS",ASSAY/Procedure,"USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Chromatographic system: Change
Column: 4.6-cm × 25-cm; packing L1
to:
Column: 4.6-mm × 25-cm; packing L1"
"PRAZOSIN HYDROCHLORIDE CAPSULES","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Test 2/Analysis: Change
CS = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Prazosin Hydrochloride RS in the Standard solution (mg/mL)
AND
Change
Mr2 = molecular weight of prazosin hydrochloride, 419.86
to:
Mr2 = molecular weight of prazosin hydrochloride, 419.87"
"ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"Change
USP 2-Methylbenzhydrol RS
to:
USP Methylbenzhydrol RS"
"ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION",Assay,"USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"Change
Constitute Erythromycin Ethylsuccinate for Oral Suspension as directed in the labeling, and proceed as directed in the Assay under Erythromycin Ethylsuccinate Oral Suspension.
to:
Constitute Erythromycin Ethylsuccinate for Oral Suspension as directed in the labeling, and proceed as directed for erythromycin under Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of the reconstituted suspension, freshly mixed and free from air bubbles, blended for 4 ± 1 minutes in a high-speed glass blender jar with sufficient methanol to give a stock solution containing the equivalent of about 1 mg of erythromycin per mL. Dilute this stock solution quantitatively with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard."
"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,31-Mar-2023,1-Apr-2023,NA,NA,"In Test 2/Analysis: Change
CS = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (ug/mL) in the Standard solution
to:
CS = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (µg/mL) in the Standard solution"
"ESCITALOPRAM TABLETS",ASSAY/Procedure,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Buffer: Change
Adjust with 1 N sodium hydroxide VS to a pH of 5.2.
to:
Adjust with 1 N sodium hydroxide to a pH of 5.2."
"<1042> CELL BANKING PRACTICES FOR RECOMBINANT BIOLOGICS","5. CELL BANK CHARACTERIZATION","USPNF Online",Online,31-Mar-2023,1-May-2023,NA,NA,"In Table 4: Change
In vitro assayd,e + + +f
to:
In vitro assayd,e + −f +"
ROSEMARY,"COMPOSITION/Content of Phenolic Diterpenes","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,"
"BISOPROLOL FUMARATE","CHEMICAL INFORMATION","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"Change
(±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropyl amino)-2-propanol fumarate (2:1) (salt)
to:
(±)-1-[[α-(2-Isoproproxyethoxy)-p-tolyl]oxy]-3-(isopropylamino)-2-propanol fumarate (2:1) (salt)"
"DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES",IDENTIFICATION,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"Change
A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
to:
A. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay."
"FLUVOXAMINE MALEATE TABLETS",ASSAY/Procedure,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Solution A: Change
8 g/L of 1-pentanesulfonic acid sodium salt and 1 g/L of monobasic potassium phosphate in water.
to:
8 g/L of 1-pentanesulfonic acid sodium salt and 1.1 g/L of monobasic potassium phosphate in water."
"RISEDRONATE SODIUM DELAYED-RELEASE TABLETS",ASSAY,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"Delete
[Note—Use a non-metallic liquid chromatography system for analysis.]"
PINDOLOL,ASSAY/Procedure,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Standard stock solution: Change
1 mg/mL of USP Pindolol RS in Mobile phase prepared as follows. To a suitable amount of USP Pindolol RS add Mobile phase to fill about 90% of the total volume, and sonicate for about 5 min to dissolve.
to:
1 mg/mL of USP Pindolol RS in Mobile phase prepared as follows. To a suitable amount of USP Pindolol RS add Mobile phase to fill about 90% of the total volume, and sonicate for about 5 min to dissolve. Dilute with Mobile phase to volume."
"TRIETHYL CITRATE",ASSAY/Procedure,"USPNF Online",Online,24-Feb-2023,1-May-2023,NA,NA,"In System suitability/Suitability requirements/Tailing factor: Change
NMT 1.5 for the triethyl citrate to trimethyl citrate peaks
to:
NMT 1.5 for the triethyl citrate and trimethyl citrate peaks"
"ESCITALOPRAM TABLETS","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Test 1/Medium: Change
0.1 N hydrochloric acid VS; 900 mL
to:
0.1 N hydrochloric acid; 900 mL
AND
In Test 2/Medium: Change
0.1 N hydrochloric acid VS; 900 mL
to:
0.1 N hydrochloric acid; 900 mL"
"POWDERED ROSEMARY","COMPOSITION/Content of Phenolic Diterpenes","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,"
ISOFLURANE,"IMPURITIES/Organic Impurities","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Analysis: Change
Result = (rU/rS) × CS × (1/F)
to:
Result = (rU/rS) × CF × (1/F)
AND
Change
CS = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)
to:
CF = final concentration of USP Isoflurane Related Compound B RS in the Standard solution (%)"
"FLUTICASONE PROPIONATE NASAL SPRAY","OTHER COMPONENTS/Content of Phenylethyl Alcohol","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Sample solution: Change
Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min until the supernatant is clear. Use the clear supernatant for analysis.
to:
Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min. Dilute with Diluent to volume, and shake. Allow to stand for 10 min until the supernatant is clear. Use the clear supernatant for analysis."
"PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS","PERFORMANCE TESTS","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"Change
Uniformity of Dosage Units 〈905〉
Procedure for content uniformity
to:
Uniformity of Dosage Units 〈905〉: Meets the requirements
Procedure for content uniformity, chewable tablets only
AND
In Uniformity of Dosage Units: Delete
Acceptance criteria: Meet the requirements for chewable tablets"
ACYCLOVIR,ASSAY/Procedure,"USPNF Online",Online,29-Apr-2022,1-May-2023,NA,NA,"In the Sample solution: Change
0.1 N sodium hydroxide
to:
0.01 N sodium hydroxide"
"ACARBOSE TABLETS",IDENTIFICATION/B.,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"Change
The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1.
to:
The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1."
"VIGABATRIN TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Analysis: Change
CS = concentration of USP Vigabatrin Related Compound A in the Standard solution
to:
CS = concentration of USP Vigabatrin Related Compound A RS in the Standard solution"
DEXTRATES,"ASSAY/Dextrose Equivalent","USPNF Online",Online,31-Mar-2023,1-May-2023,NA,NA,"In Analysis: Change
rA = peak response of each saccharide degree of polymerization (DP1–DP3) in the Sample solution (If any peaks of DP4 and above are observed in the sample, take the summation of all peak responses DP4+ and use this value as rU.)
to:
rA = peak response of each saccharide degree of polymerization (DP1–DP3) in the Sample solution (If any peaks of DP4 and above are observed in the sample, take the summation of all peak responses DP4+ and use this value as rA.)"
"ROSEMARY LEAF DRY AQUEOUS EXTRACT","COMPOSITION/Content of Rosmarinic Acid","USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Standard solution B: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
AND
In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,"
"BUPIVACAINE HYDROCHLORIDE INJECTION",ASSAY/Procedure,"USPNF Online",Online,28-Apr-2023,1-May-2023,NA,NA,"In Chromatographic system/Column: Change
4-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
AND
In System suitability: Change
[Note—The relative retention times for bupivacaine hydrochloride and dibutyl phthalate are about 1.0 and 1.2, respectively.]
to:
[Note—The relative retention times for bupivacaine and dibutyl phthalate are about 1.0 and 1.2, respectively.]
AND
In System suitability/Suitability requirements: Change
Resolution: NLT 2.0 between bupivacaine hydrochloride and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the ratio of bupivacaine to the internal standard from three replicate injections
to:
Resolution: NLT 2.0 between bupivacaine and dibutyl phthalate
Relative standard deviation: NMT 1.0% for the peak response ratio of bupivacaine to the internal standard from three replicate injections"
"OSELTAMIVIR PHOSPHATE","IMPURITIES/Organic Impurities/Procedure 3: Limit Of Tributyl Phosphine Oxide","USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 10.0% for the tributyl phosphine oxide and osteltamivir phosphate peaks
to:
NMT 10.0% for the tributyl phosphine oxide and oseltamivir phosphate peaks"
"METHYLPHENIDATE HYDROCHLORIDE","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"In USP Methylphenidate Related Compound A RS: Change
α-Phenyl-2-piperidineacetic acid hydrochloride.
to:
(RS)-2-Phenyl-2-[(RS)-piperidin-2-yl]acetic acid hydrochloride."
MESO-ZEAXANTHIN,"COMPOSITION/Stereoisomeric Composition","USPNF Online",Online,27-Jan-2023,1-Jun-2023,NA,NA,"In System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
to:
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.94, 1.00, 1.06, and 1.11, respectively.]
AND
In System suitability/Suitability requirements/Resolution: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Acceptance criteria: Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin"
"LYSINE HYDROCHLORIDE","IMPURITIES/Related Compounds","USPNF Online",Online,16-Dec-2022,1-Jun-2023,NA,NA,"In Chromatographic system/Spray reagent: Change
0.2 g of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
to:
2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)"
"LINEZOLID TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"In Sensitivity solution: Change
0.5 ug/mL of USP Linezolid RS from Standard solution in Diluent
to:
0.5 μg/mL of USP Linezolid RS from Standard solution in Diluent"
MESO-ZEAXANTHIN,"CHEMICAL INFORMATION","USPNF Online",Online,27-Jan-2023,1-Jun-2023,NA,NA,"Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin"
"METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"In USP Methylphenidate Related Compound A RS: Change
α-Phenyl-2-piperidineacetic acid hydrochloride.
to:
(RS)-2-Phenyl-2-[(RS)-piperidin-2-yl]acetic acid hydrochloride."
MESO-ZEAXANTHIN,"ADDITIONAL REQUIREMENTS/USP Reference Standards <11>","USPNF Online",Online,27-Jan-2023,1-Jun-2023,NA,NA,"In USP meso-Zeaxanthin RS: Change
(3R,3′S-meso)-Zeaxanthin.
to:
(3R,3′S)-Zeaxanthin."
"<251> LEAD","PROCEDURES/Procedure 1: Chemical Method","USPNF Online",Online,27-Jan-2023,1-Jun-2023,NA,NA,"In Analysis: Change
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonia cyanide solution,
to:
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonium cyanide solution,"
GLYCYL-L-TYROSINE,"IMPURITIES/Related Compounds","USPNF Online",Online,24-Feb-2023,1-Jun-2023,NA,NA,"In Buffer solution: Change
Dissolve 6.84 g of potassium phosphate in 1000 mL of water.
to:
Dissolve 6.84 g of monobasic potassium phosphate in 1000 mL of water."
"LYSINE ACETATE","IMPURITIES/Related Compounds","USPNF Online",Online,16-Dec-2022,1-Jun-2023,NA,NA,"In Chromatographic system/Spray reagent: Change
0.2 g of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
to:
2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)"
"MILBEMYCIN OXIME","CHEMICAL INFORMATION","USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"Change
541.68
Milbemycin B, 5-O-demethyl-28-deoxy-25-methyl-6,28-epoxy-23-hydroxyimino-, [6R,23S,25S(E)]-; (2αE,4E,5′S,6R,6′S,8E,11R,13R,15S,17αR,20αR,20βS)-3′,4′,5′,6,6′,7,10,11,14,15,17α,20,20α,20β-tetradecahydro-20β-hydroxy-5′,6′,6,8,19-pentamethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-17-one 20-oxime.
to:
541.69
Milbemycin B, 5-demethoxy-28-deoxy-6,28-epoxy-5-(hydroxyamino)-25-methyl-, (6R,25R)-; (2R,2a′E,2a1′S,4′E,5S,6R,6′R,8′E,11′R,15′S,17a′R,20′Z,20a′R)-2a1′-Hydroxy-20′-(hydroxyimino)-5,6,6′,8′,19′-pentamethyl-2a1′,3,4,5,6,6′,7′,10′,11′,14′,15′,17a′,20′,20a′-tetradecahydro-2′H,17′H-spiro[pyran-2,13′-[11,15]methano[1,5]dioxacyclooctadecino[9,8,7-cd]benzofuran]-17′-one.
AND
Change
555.70
Milbemycin B, 5-O-demethyl-28-deoxy-25-ethyl-6,28-epoxy-23-hydroxyimino-, [6R,23S,25S(E)]-; (2αE,4E,5′S,6R,6′S,8E,11R,13R,15S,17αR,20αR,20βS)-6′-ethyl-3′,4′,5′,6,6′,7,10,11,14,15,17α,20,20α,20β-tetradecahydro-20β-hydroxy-5′,6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-17-one 20-oxime.
to:
555.71
Milbemycin B, 5-demethoxy-28-deoxy-6,28-epoxy-25-ethyl-5-(hydroxyamino)-, [6R,25R]-; (2R,2a′E,2a1′S,4′E,5S,6R,6′R,8′E,11′R,15′S,17a′R,20′Z,20a′R)-6-Ethyl-2a1′-hydroxy-20′-(hydroxyimino)-5,6′,8′,19′-tetramethyl-2a1′,3,4,5,6,6′,7′,10′,11′,14′,15′,17a′,20′,20a′-tetradecahydro-2′H,17′H-spiro[pyran-2,13′-[11,15]methano[1,5]dioxacyclooctadecino[9,8,7-cd]benzofuran]-17′-one."
MESO-ZEAXANTHIN,IDENTIFICATION/C.,"USPNF Online",Online,27-Jan-2023,1-Jun-2023,NA,NA,"Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin"
ATOVAQUONE,IMPURITIES,"USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"Change
Related Compounds
System suitability solution and Sample solution: Prepare as directed in the Assay.
Analysis
Samples: System suitability solution and Sample solution
Using the chromatograms of the Sample solution and the System suitability solution, calculate the percentage of atovaquone related compounds in the portion of Atovaquone taken:
to:
Organic Impurities
Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, Chromatographic system and System suitability: Proceed as directed in the Assay.
Analysis
Sample: Sample solution
Calculate the percentage of atovaquone related compounds in the portion of Atovaquone taken:"
"ATORVASTATIN CALCIUM","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,26-May-2023,1-Jun-2023,NA,NA,"Change
USP Atorvastatin Related Compound H RS (lactone impurity)
to:
USP Atorvastatin Related Compound H RS
Also known as Lactone impurity;
AND
Change
USP Atorvastatin Related Compound I RS (acetonide impurity)
to:
USP Atorvastatin Related Compound I RS
Also known as Acetonide impurity;"
"<251> LEAD","REQUIREMENTS FOR PROCEDURE VALIDATION","USPNF Online",Online,27-Jan-2023,1-Jun-2023,NA,NA,"Change
• Precision Repeatability
to:
• Precision"
"ATORVASTATIN CALCIUM TABLETS",ASSAY/Procedure,"USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In Analysis: Change
Mr1 = molecular weight of atorvastatin, 558.64
Mr2 = molecular weight of atorvastatin calcium, 1155.34
to:
Mr1 = molecular weight of atorvastatin, 558.65
Mr2 = molecular weight of atorvastatin calcium, 1155.36"
"METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"Change
USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS (USP Methacrylic Acid Copolymer, Type C RS)
to:
USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS (USP Methacrylic Acid Copolymer Type C RS)"
"DIGOXIN TABLETS",ASSAY/Procedure,"USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In Chromatographic system: Change
Column: 4.2-mm × 25-cm; 5-μm packing L1
to:
Column: 4.6-mm × 25-cm; 5-µm packing L1"
"RISEDRONATE SODIUM DELAYED-RELEASE TABLETS","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In Buffer stage/Analysis: Change
Calculate the percentage of the labeled amount of risedronate sodium (C7H10NNaO7P7) dissolved:
to:
Calculate the percentage of the labeled amount of risedronate sodium (C7H10NNaO7P2) dissolved:"
"ATORVASTATIN CALCIUM TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In Analysis: Change
Mr1 = molecular weight of atorvastatin, 558.64
Mr2 = molecular weight of atorvastatin calcium, 1155.34
to:
Mr1 = molecular weight of atorvastatin, 558.65
Mr2 = molecular weight of atorvastatin calcium, 1155.36"
"ATORVASTATIN CALCIUM TABLETS","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In Test 1, Test 3, Test 4, Test 5, and Test 6/Analysis: Change
Mr1 = molecular weight of atorvastatin, 558.64
Mr2 = molecular weight of atorvastatin calcium, 1155.34
to:
Mr1 = molecular weight of atorvastatin, 558.65
Mr2 = molecular weight of atorvastatin calcium, 1155.36"
"METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER",IDENTIFICATION/A.,"USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"Change
USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS
to:
USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS (USP Methacrylic Acid Copolymer Type C RS)"
"SITAGLIPTIN PHOSPHATE","IMPURITIES/Organic Impurities","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In Analysis: Change
CS = concentration of USP Sitagliptin Phosphate in the Standard solution (mg/mL)
to:
CS = concentration of USP Sitagliptin Phosphate RS in the Standard solution (mg/mL)"
TIOCONAZOLE,"ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In USP Tioconazole Related Compound A RS: Change
389.73
to:
389.72
AND
In USP Tioconazole Related Compound B RS: Change
458.62
to:
458.60
AND
In USP Tioconazole Related Compound C RS: Change
C16H13BrCl2N2OS · HCl 468.63
to:
C16H12BrCl3N2OS · HCl 503.06"
"ATORVASTATIN CALCIUM TABLETS","ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉","USPNF Online",Online,30-Jun-2023,1-Jul-2023,NA,NA,"In USP Atorvastatin Related Compound B RS: Change
1155.34
to:
1155.36"
"TRIMETHOBENZAMIDE HYDROCHLORIDE","CHEMICAL INFORMATION","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"Change
N-[p-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxy benzamide monohydrochloride
to:
N-[4-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride"
"PURIFIED SILICEOUS EARTH",IMPURITIES,"USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"In Leachable Arsenic/Analysis: Change
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure.
to:
A 3.0-mL portion of the Sample solution meets the requirements in Arsenic 〈211〉, Procedures, Procedure 1."
"CLOMIPHENE CITRATE TABLETS","IMPURITIES/Organic Impurities","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"In Table 2: Change
Clomiphene related compound A 0.87 – 2.0
to:
Clomiphene related compound A 0.87 1.0 2.0"
"CHLORTETRACYCLINE HYDROCHLORIDE","CHEMICAL INFORMATION","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"Change
7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride
to:
(4S,4aS,5aS,6S,12aS)-7-Chloro-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide monohydrochloride"
"AZITHROMYCIN FOR INJECTION",IMPURITIES,"USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,"USPNF 2024 Issue 2","In footnote m in Table 2: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one."
"CALCIUM ASCORBATE",IDENTIFICATION/A.,"USPNF Online",Online,26-May-2023,1-Aug-2023,NA,NA,"Change
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
to:
Characteristic emission lines for calcium at 184.0, 315.9, and 317.9 nm from the Sample solution correspond to those from the Standard solution, as obtained in the Content of Calcium."
"LEVORPHANOL TARTRATE TABLETS","PERFORMANCE TESTS/Uniformity of Dosage Units 〈905〉","USPNF Online",Online,31-Mar-2023,1-Aug-2023,NA,NA,"In Sample solution: Change
Nominally about 80 ug/mL of levorphanol tartrate in Diluent prepared as follows.
to:
Nominally about 80 µg/mL of levorphanol tartrate in Diluent prepared as follows."
"REAGENTS AND REFERENCE TABLES","Reagent Specifications/Tosylchloramide Sodium","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,Change
127-65-1
to:
7080-50-4
"POLYVINYL ALCOHOL",IMPURITIES,"USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"In Limit of Methanol (Methyl Alcohol) and Methyl Acetate/Analysis: Change
CU = concentration of methanol (methyl alcohol) or methyl acetate in the Sample solution (mg/mL)
to:
CU = concentration of Polyvinyl Alcohol in the Sample solution (mg/mL)"
"POLYETHYLENE GLYCOL 12 CETOSTEARYL ETHER",IDENTIFICATION,"USPNF Online",Online,28-Apr-2023,1-Aug-2023,NA,NA,"Change:
B. Test for Hydroxyl Group:
to:
B. Hydroxyl Value:
AND
In D./Analysis: Change
Dissolve or disperse the Sample in alcohol.
to:
Dissolve or disperse the Sample in 5 mL alcohol."
PIPERACILLIN,"SPECIFIC TESTS","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"In Sterility Tests 〈71〉: Change
Where the label states that Piperacillin is sterile or that it must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration.
to:
Where the label states that Piperacillin is sterile, it meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration."
"AZITHROMYCIN FOR INJECTION","ADDITIONAL REQUIREMENTS","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,"USPNF 2024 Issue 2","In USP Reference Standards 〈11〉/USP Azaerythromycin A RS: Change
734.96
to:
734.97
AND
In USP Azithromycin N-oxide RS: Change
764.98
to:
765.00
AND
In USP N-Demethylazithromycin RS: Change
734.96
to:
734.97
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80"
"CALCIUM ASCORBATE",ASSAY/Procedure,"USPNF Online",Online,30-Jun-2023,1-Aug-2023,NA,NA,"In Analysis: Change
Mr1 = molecular weight of calcium ascorbate dihydrate, 426.43
to:
Mr1 = molecular weight of calcium ascorbate dihydrate, 426.34"
"TRIAZOLAM TABLETS","PERFORMANCE TESTS/Dissolution 〈711〉","USPNF Online",Online,28-Jul-2023,1-Aug-2023,NA,NA,"In Standard solution: Change
Tablet/mg
to:
mg/Tablet"
"DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION",Assay,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Chromatographic system and Procedure: Change
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS, on the anhydrous basis, in the Standard preparation;
to:
C is the concentration, in mg per mL, of USP Dextromethorphan Hydrobromide RS in the Standard preparation;"
"SODIUM ALGINATE",ASSAY,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Procedure/Analysis: Change
Result = (V2 × N × WE)/(W × D)
to:
Result = (V2 × N × WE × 10)/(W × D)"
"FOSAMPRENAVIR CALCIUM TABLETS","PERFORMANCE TESTS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Dissolution 〈711〉/Medium: Change
26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL.
to:
0.02 M sodium acetate buffer, pH 3.5, prepared as follows. Dissolve 2.67 g of sodium acetate in 100 mL of water. Add 13.3 mL of glacial acetic acid and then dilute with water to 1000 mL; 900 mL."
"ZIPRASIDONE HYDROCHLORIDE",IMPURITIES,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Organic Impurities/Solution B: Change
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0.
to:
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution to a pH of 6.0.
AND
In both equations in Organic Impurities/Analysis: Change
449.40
to:
449.39"
"REAGENTS AND REFERENCE TABLES","Solutions/Test Solutions and Indicator Solutions/Starch TS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"Change
Prepare this solution by one of the following procedures:
to:
Prepare this solution by one of the following procedures. Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions or commercially bought solutions.
AND
In Storage: Delete
Use the Test for sensitivity to confirm suitability for use.
AND
In Procedure with No Preservative: Delete
Apply the Test for sensitivity to confirm suitability for freshly or previously prepared solutions.
AND
In Test for sensitivity: Delete
Use the Test for sensitivity to confirm suitability for use.
AND
In Procedure with Salicylic Acid as Preservative: Change
Mix 1 g of soluble starch with 50 mL of cold water
to:
Mix 1 g of soluble starch with 5 mL of cold water"
"BLACK CUMIN SEED THYMOQUINONE OIL",DEFINITION,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,Change
carvacol
to:
carvacrol
"CRANBERRY FRUIT DRY JUICE",COMPOSITION,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Content of Proanthocyanidins/Standard stock solution: Change
USP Procyanidin A2 RS
to:
USP Procyanidin A2 RS
AND
In Content of Proanthocyanidins/Analysis: Change
Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution.
to:
Use the absorbance recorded for Standard solutions 1–5 to obtain a calibration curve (absorbance vs. concentration, in µg/mL, of procyanidin A2) and perform a linear regression analysis. Determine the concentration (C), in µg/mL, of total proanthocyanidins as procyanidin A2 in the Sample solution.
AND
In Content of Proanthocyanidins/Analysis: Change
C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL)
to:
C = concentration of the Sample solution as procyanidin A2 from the regression line (µg/mL)
AND
In Content of Proanthocyanidins/Acceptance criteria: Change
procyanidin A2
to:
procyanidin A2"
"ZIPRASIDONE CAPSULES","PERFORMANCE TESTS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Dissolution 〈711〉/Test 1/Tier 1/Phosphate buffer, pH 7.5: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 1/Tier 1/Analysis: Change
449.40
to:
449.39
AND
In Dissolution 〈711〉/Test 1/Tier 2/Solution A and Solution B: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 2/Tier 2/Analysis: Change
449.40
to:
449.39
AND
In Dissolution 〈711〉/Test 3/Tier 2/Analysis: Change
449.40
to:
449.39"
AZITHROMYCIN,"ADDITIONAL REQUIREMENTS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In USP Reference Standards 〈11〉/USP Azaerythromycin A RS: Change
734.96
to:
734.97
AND
In USP Azithromycin Related Compound F RS: Change
762.97
to:
762.98
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80"
"AMANTADINE HYDROCHLORIDE",IDENTIFICATION,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In A.: Change
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, and 197S
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197A, 197K, or 197S
Procedure for 197S"
"CRANBERRY FRUIT DRY JUICE",DEFINITION,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"Change
procyanidin A2
to:
procyanidin A2"
OCTOCRYLENE,IDENTIFICATION,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In A./Acceptance criteria: Change
NMT 3.0%, calculated on the as-is basis
to:
Absorptivities, calculated on the as-is basis, do not differ by more than 3.0%."
AZITHROMYCIN,"CHEMICAL INFORMATION","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,Change
748.98
to:
749.00
AND
Change
767.00
to:
767.01
AND
Change
785.02
to:
785.03
"UREA C 13",IMPURITIES,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Isotopic Purity/Chromatographic system: Change
Flow rate: Flow rate
to:
Flow rate: 1 mL/min"
"BLACK CUMIN SEED THYMOQUINONE OIL","SPECIFIC TESTS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Fats and Fixed Oils 〈401〉, Procedures, Fatty Acid Composition/Table 2: Change
Linoleic
to:
Linoleic acid"
"CRANBERRY FRUIT DRY JUICE","ADDITIONAL REQUIREMENTS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In USP Reference Standards 〈11〉: Change
USP Procyanidin A2 RS
to:
USP Procyanidin A2 RS"
"ZIPRASIDONE CAPSULES",IMPURITIES,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Organic Impurities/Solution B: Change
potassium hydroxide
to:
potassium hydroxide solution
AND
In Organic Impurities/Analysis: Change
449.40
to:
449.39"
"VALGANCICLOVIR HYDROCHLORIDE",IMPURITIES,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Organic Impurities/Table 3/footnote c: Change
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]-2-hydroxypropyl methyl-L-valinate hydrochloride.
to:
3-[(2-Amino-6-oxo-1,6-dihydropurin-9-yl)methoxy]-2-hydroxypropyl L-valinate hydrochloride."
"ARIPIPRAZOLE TABLETS","PERFORMANCE TESTS","USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Dissolution <711>/Test 1/Procedure/Chromatographic procedure/Analysis: Change
Result = (RU/RS) × CS × V × (1/L) × 100
to:
Result = (RU/RS) × CS × V × D × (1/L) × 100
AND
Add
D = dilution factor of the Sample solution, 2"
"CRANBERRY FRUIT DRY JUICE",IDENTIFICATION,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In A./Standard solution B: Change
USP Procyanidin A2 RS
to:
USP Procyanidin A2 RS
AND
In A./System suitability/Suitability requirements/Derivatization reagent B/White light: Change
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in RF and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section.
to:
Standard solution B exhibits two brown bands in the upper-half section corresponding to procyanidin A2 and epicatechin. Standard solution C exhibits two brown bands in the upper-half section corresponding in RF and color to procyanidin A2 and epicatechin in Standard solution B. Standard solution C also exhibits a series of faint or indistinct brown bands of differing intensities below procyanidin A2 in the lower-half section.
AND
In A./Acceptance criteria/Derivatization reagent B/White light: Change
The Sample solution exhibits two faint brown bands corresponding in RF to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in RF to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2.
to:
The Sample solution exhibits two faint brown bands corresponding in RF to procyanidin A2 and epicatechin in Standard solution B. The Sample solution also exhibits a series of faint or indistinct brown bands of differing intensities in the lower-half section, corresponding to the same bands in Standard solution C. No bands corresponding in RF to epigallocatechin-3-O-gallate, procyanidin B2, or procyanidin B1 appear below procyanidin A2.
AND
In C./Acceptance criteria/Profile at 520 nm: Change
cyanidin-3-O-arabinose,
to:
cyanidin-3-O-arabinoside,
AND
In C./Acceptance criteria/Profile at 520 nm: Change
peonidin-3-O-arabinose
to:
peonidin-3-O-arabinoside"
"ZIPRASIDONE CAPSULES",ASSAY,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Procedure/Analysis: Change
449.40
to:
449.39"
AZITHROMYCIN,IMPURITIES,"USPNF Online",Online,25-Aug-2023,1-Sep-2023,NA,NA,"In Organic Impurities/Table 2: Change:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycinm
to:
3’-N-Demethyl-3’-N-[(4-methylphenyl)sulfonyl]azithromycinm
AND
In Organic Impurities/Table 2/footnote m: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one."
"DIGOXIN TABLETS",ASSAY,"USPNF Online",Online,29-Sep-2023,1-Oct-2023,NA,NA,"In Procedure/Analysis: Change
CU = nominal concentration of in the Sample solution (µg/mL)
to:
CU = nominal concentration of digoxin in the Sample solution (µg/mL)"
"DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS","PERFORMANCE TESTS","USPNF Online",Online,29-Sep-2023,1-Oct-2023,NA,NA,"In Dissolution 〈711〉/Test 8/Tolerances: Change
The percentage of the labeled amount of valproic acid (C8H16O2) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 1.
to:
The percentage of the labeled amount of valproic acid (C8H16O2) dissolved at the times specified conform to Dissolution <711>, Acceptance Table 2."
"TAMSULOSIN HYDROCHLORIDE CAPSULES",IMPURITIES,"USPNF Online",Online,29-Sep-2023,1-Oct-2023,NA,NA,"In Organic Impurities/System suitability: Change
Sample: Standard solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 5.0%
Signal-to-noise ratio: NLT 10
to:
Samples: Standard solution and Sensitivity solution
[Note—The relative retention times for methoxy tamsulosin, tamsulosin, ethoxyphenoxy ethyl bromide, and desethoxy tamsulosin are 0.73, 1.00, 1.80, and 2.80, respectively.]
Suitability requirements
Tailing factor: NMT 2.0, Standard solution
Relative standard deviation: NMT 5.0%, Standard solution
Signal-to-noise ratio: NLT 10, Sensitivity solution"
"OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES",STRENGTH,"USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Vitamin A, Method 3/Analysis: Change
CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
CS = concentration of retinyl acetate (C22H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)"
UREA,"SPECIFIC TESTS","USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Alcohol-Insoluble Matter/Sample solution: Change
100 mg/mL of Urea dissolved in warm alcohol
to:
Dissolve 5.0 g of Urea in 50 mL of warm alcohol.
AND
In Alcohol-Insoluble Matter/Analysis: Change
If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol per 50 mL of Sample solution, and dry at 105° for 1 h.
to:
If any insoluble residue remains, pass the Sample solution through a tared filter, wash the residue and the filter with 20 mL of warm alcohol, and dry at 105° for 1 h."
"TELMISARTAN TABLETS",ASSAY,"USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Procedure/System suitability/Suitability requirements: Change
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for the telmisartan peak
Capacity factor: NLT 1.5
Relative standard deviation: NMT 2.0%
to:
Resolution: NLT 3 between telmisartan and telmisartan related compound A
Tailing factor: NMT 2.0 for telmisartan
Relative standard deviation: NMT 2.0% for telmisartan"
"OIL-SOLUBLE VITAMINS CAPSULES",STRENGTH,"USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Vitamin A, Method 3/Analysis: Change
CS = concentration of retinyl acetate (C23H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)
to:
CS = concentration of retinyl acetate (C22H32O2) from USP Vitamin A RS in the Standard solution (μg/mL)"
"PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS",ASSAY,"USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Procedure/System suitability/Tailing factor: Change
NMT 2.0, System suitability solution
to:
NMT 2.0 for pantoprazole, System suitability solution"
"TELMISARTAN TABLETS","PERFORMANCE TESTS","USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Dissolution 〈711〉/Test 1/Analysis: Change
Determine the percentage of telmisartan (C33H30N4O2) dissolved:
Result = (AU × CS × V × 100)/(AS × D × L)
to:
Calculate the percentage of the labeled amount of telmisartan (C33H30N4O2) dissolved:
Result = (AU/AS) × CS × V × D × (1/L) × 100
AND
Change
CS = concentration of the Standard solution (mg/mL)
to:
CS = concentration of USP Telmisartan RS in the Standard solution (mg/mL)
AND
In Dissolution 〈711〉/Test 2/Analysis: Change
rU = peak response from the Sample solution
rS = peak response from the Standard solution
to:
rU = peak response of telmisartan from the Sample solution
rS = peak response of telmisartan from the Standard solution
AND
In Dissolution 〈711〉/Test 3/Analysis: Change
CS = concentration of the Standard solution (mg/mL)
to:
CS = concentration of USP Telmisartan RS in the Standard solution (mg/mL)"
"METHYLBENZETHONIUM CHLORIDE",ASSAY,"USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"In Procedure/Analysis: Change
Calculate the percentage of methylbenzethonium chloride (C28H44ClNO2 · H2O) in the portion of Methylbenzethonium Chloride taken:
to:
Calculate the percentage of methylbenzethonium chloride (C28H44ClNO2) in the portion of Methylbenzethonium Chloride taken:"
"AMOXICILLIN FOR INJECTABLE SUSPENSION",Identification,"USPNF Online",Online,27-Oct-2023,1-Nov-2023,NA,NA,"Change
Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution."
"<631> COLOR AND ACHROMICITY","METHOD II: INSTRUMENTAL (QUANTITATIVE) ASSESSMENT OF COLOR AND COLOR MATCHES","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Table 5: Change
Sum 98.809 100.000 107.307
White point 98.811 100.000 107.304
to:
Sum 94.809 100.000 107.307
White point 94.811 100.000 107.304"
AZITHROMYCIN,IMPURITIES,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Organic Impurities/Table 2: Change
3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycinm
to:
3′-N-{[4-(Acetylamino)phenyl]sulfonyl}-3′-demethylazithromycinm
AND
In Table 2/footnote m: Change
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
to:
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-acetamidophenylsulfonyl)-N-methylamino]-3,4,6-trideoxy-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one."
"OLMESARTAN MEDOXOMIL TABLETS","PERFORMANCE TESTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Dissolution 〈711〉/Test 5/Apparatus 2: Change
50 rpm. Use peak vessels.
to:
50 rpm. Use apex vessels."
CEFDINIR,"ADDITIONAL REQUIREMENTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42"
"AMOXICILLIN BOLUSES",IDENTIFICATION,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"Change
Application volume, Developing solvent system, Procedure—Proceed as directed for the Identification test under Amoxicillin Tablets.
to:
Application volume—5 µL.
Developing solvent system—a mixture of methanol, chloroform, water, and pyridine (90:80:30:10).
Procedure—Proceed as directed in Thin-Layer Chromatographic Identification Test <201>. Dry the plate with the aid of a current of warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes."
"DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES","ADDITIONAL REQUIREMENTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In USP Reference Standards 〈11〉/USP Dihydrodutasteride RS: Change
N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide.
to:
N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androstane-17β-carboxamide."
"Strychnine Sulfate","REAGENTS AND REFERENCE TABLES","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Reagent Specifications: Change
CAS RN®: 60-41-3.
to:
CAS RN®: 60491-10-3."
"<915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY",APPARATUS,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Figure 2: Change
66±0.25 Ø
to:
65±0.25 Ø"
"DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS","PERFORMANCE TESTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Dissolution 〈711〉: Move Test 2 after Test 1"
"PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS","PERFORMANCE TESTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
to:
Acid stage standard solution: (L/10000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim in mg/Tablet
AND
In Dissolution <711>/Test 2/Buffer stage: Change
Buffer stage standard solution: (L/1000) of USP Pantoprazole Sodium RS where L is the label claim in mg/Tablet
to:
Buffer stage standard solution: (L/1000) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Buffer stage medium, where L is the label claim in mg/Tablet"
"CEFDINIR CAPSULES","ADDITIONAL REQUIREMENTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C14H13N4O4S2 365.41
to:
C14H14N4O4S2 366.41"
"AMOXICILLIN INTRAMAMMARY INFUSION",IDENTIFICATION,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"Change
The solution obtained responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 4 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography <621>). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution."
NORFLURANE,IMPURITIES,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Organic Impurities/Table 2: Change
Line No.
to:
Peak Elution Order
AND
In Halides/Figure 1: Add label
Flow Meter"
CEFDINIR,IMPURITIES,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Organic Impurities/Table 2/footnote a: Change
1N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine.
to:
N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine."
"<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS","SPECIFIC TESTS FOR TDS","USPNF Online",Online,28-Jul-2023,1-Dec-2023,NA,NA,"In Release Liner Peel Test: Change
The product fails the test if the mean peel force is outside the acceptable range determined during product development.
to:
The product fails the test if the overall mean peel force is outside the acceptable range determined during product development."
"AMIKACIN SULFATE",ASSAY,"USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Procedure/Analysis: Change
CU = concentration of amikacin in the Sample solution (mg/mL)
to:
CU = concentration of Amikacin Sulfate in the Sample solution (mg/mL)"
"DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES","PERFORMANCE TESTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change
10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL
to:
Dissolve 10 g of cetyltrimethylammonium bromide and 1.6 g of pepsin, purified in 1000 mL of 0.1 N hydrochloric acid; 900 mL"
"SODIUM SALICYLATE","ADDITIONAL REQUIREMENTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In USP Reference Standards 〈11〉: Add
USP Phenol RS"
"CEFDINIR FOR ORAL SUSPENSION","ADDITIONAL REQUIREMENTS","USPNF Online",Online,17-Nov-2023,1-Dec-2023,NA,NA,"In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C14H13N4O4S2 365.41
to:
C14H14N4O4S2 366.41"
GLUCAGON,"PROCESS-RELATED IMPURITIES AND OTHER COMPONENTS","USPNF Online",Online,29-Dec-2023,1-Jan-2024,NA,NA,"In Acetic Acid in Peptides/Analysis: Change
CSPA = concentration of potassium acetate in each of the Standard solutions (mg/mL)
to:
CSPA = concentration of potassium acetate in each of the Standard solutions (µg/mL)
AND
In Ammonium/Analysis: Change
CSAC = concentration of ammonium chloride in each of the Standard solutions (mg/mL)
to:
CSAC = concentration of ammonium chloride in each of the Standard solutions (µg/mL)"
"<81> ANTIBIOTICS—MICROBIAL ASSAYS",APPENDICES,"USPNF Online",Online,29-Dec-2023,1-Jan-2024,NA,NA,"In two instances in Appendix 1 equations: Change
14.020
to:
14.022"
"SECOBARBITAL SODIUM","OTHER REQUIREMENTS","USPNF Online",Online,29-Dec-2023,1-Jan-2024,NA,NA,"Change
Where the label states that Seco barbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and for Bacterial endotoxins under Secobarbital Sodium for Injection. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Secobarbital Sodium for Injection.
to:
Where the label states that Secobarbital Sodium is sterile, it meets the requirements for Sterility Tests 〈71〉 and the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>. Where the label states that Secobarbital Sodium must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is not more than 0.9 USP Endotoxin Units per mg of secobarbital sodium tested per Bacterial Endotoxins Test <85>."
ACARBOSE,IMPURITIES,"USPNF Online",Online,29-Dec-2023,1-Jan-2024,NA,NA,"In Chromatographic Purity/Analysis: Change
Result = (rU/rA) × (1/F) × 100
to:
Result = (rU/rA) × (1/F)"
"LINEZOLID TABLETS","PERFORMANCE TESTS","USPNF Online",Online,26-Jan-2024,1-Feb-2024,NA,NA,"In Dissolution 〈711〉/Test 1/Analysis: Change
Result = (rU/rS) × CS × V × (1/L) × 100
rU = peak response of linezolid from the Sample solution
rS = peak response of linezolid from the Standard solution
CS = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
to:
Result = (rU/rS) × CS × V × (1/L) × D × 100
rU = peak response of linezolid from the Sample solution
rS = peak response of linezolid from the Standard solution
CS = concentration of USP Linezolid RS in the Standard solution (mg/mL)
V = volume of Medium, 900 mL
L = label claim (mg/Tablet)
D = dilution factor of the Sample solution, as needed"
"CARVEDILOL TABLETS","PERFORMANCE TESTS","USPNF Online",Online,26-Jan-2024,1-Feb-2024,NA,NA,"In Dissolution <711>/Test 3/Chromatographic system/Column: Change
4.6-mm × 15-mm; 5-μm packing L7
to:
4.6-mm × 15-cm; 5-μm packing L7"
"THEOPHYLLINE CAPSULES",IDENTIFICATION,"USPNF Online",Online,26-Jan-2024,1-Feb-2024,NA,NA,"Change
A: The contents of the Capsules respond to Identification tests A and B under Theophylline Tablets.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
to:
A: Triturate a quantity of the contents of Capsules, equivalent to about 500 mg of theophylline, with 10-mL and 5-mL portions of solvent hexane, and discard the solvent hexane. Triturate the residue with two 10-mL portions of a mixture of equal volumes of 6 N ammonium hydroxide and water, and filter each time. Evaporate the combined filtrates to about 5 mL, neutralize, if necessary, with 6 N acetic acid, using litmus, and then cool to about 15°, with stirring. Collect the precipitate on a filter, wash it with cold water, and dry at 105° for 2 hours: the theophylline so obtained melts between 270° and 274° (see Melting Range or Temperature 〈741〉, Procedures, Procedure for Class I). Retain the remaining portion of the theophylline for use in Identification test B.
B: The IR absorption spectrum of a potassium bromide dispersion of the residue obtained in Identification test A exhibits maxima only at the same wavenumbers as that of a potassium bromide dispersion of USP Theophylline RS.
C: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay."
"DICYCLOMINE HYDROCHLORIDE",IDENTIFICATION,"USPNF Online",Online,26-Jan-2024,1-Feb-2024,NA,NA,"In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change
Meets the requirements when tested as specified in test B.
to:
Meets the requirements of the test for amine hydrochlorides"
"AMOXICILLIN ORAL SUSPENSION",IDENTIFICATION,"USPNF Online",Online,26-Jan-2024,1-Feb-2024,NA,NA,"Change
Shake a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. The solution responds to the Identification test under Amoxicillin Capsules.
to:
Prepare a test solution by shaking a portion of Oral Suspension with a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing about 1 mg of amoxicillin per mL. Prepare a Standard solution of USP Amoxicillin RS in 0.1 N hydrochloric acid containing 1 mg per mL. Use within 10 minutes after preparation. Apply separately 5 µL of each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 〈621〉). Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of methanol, chloroform, water, and pyridine (90:80:30:10). When the solvent front has moved about three-fourths of the length of the plate, remove the plate from the chamber, and dry with warm air for 10 minutes. Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3 mg per mL, and dry at 110° for 15 minutes: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution."
METOLAZONE,IMPURITIES,"USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"In Organic Impurities/Chromatographic system/Column: Change
4.6-mm × 25-cm; 5-µm packing 1
to:
4.6-mm × 25-cm; 5-µm packing L1"
"IODIXANOL INJECTION","ADDITIONAL REQUIREMENTS","USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"In USP Reference Standards 〈11〉/USP Iodixanol Related Compound E RS: Change
5-[[3-[[3-[[(2,3-Dihydroxypropyl)amino]carbonyl]-5- [[amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl]-(acetylimino)]-N,N′-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide.
to:
5-{N-[3-(N-{3-Carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl}acetamido)-2-hydroxypropyl]acetamido}-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide."
"FLURAZEPAM HYDROCHLORIDE","USP REFERENCE STANDARDS 〈11〉","USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"In USP Flurazepam Related Compound C RS: Change
5-Chloro-2-(2-diethylaminoethyl(amino)-2′-fluorobenzophenone hydrochloride.
to:
5-Chloro-2-(2-diethylaminoethylamino)-2′-fluorobenzophenone hydrochloride."
PROPOFOL,ASSAY,"USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"In Procedure 2/Mobile phase: Change
Hexane, acetonitrile, and alcohol (990: 7.5: 1)
to:
Hexane, acetonitrile, and alcohol, absolute (990: 7.5: 1)"
"METHYLNALTREXONE BROMIDE","CHEMICAL INFORMATION","USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"Correct the chemical structure"
"IODIXANOL INJECTION",IMPURITIES,"USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"In Organic Impurities, Procedure 2/footnote 4: Change
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy droxypropyl]oxy]-2-hydroxypropyl](acetylimino)]-N,N'-bis(2,3-dihy droxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide.
to:
5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylamino)]-2-hydroxypropyl](acetylamino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hydroxypropyl]oxy]-2-hydroxypropyl](acetylamino)]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzendicarboxamide."
"THALIDOMIDE CAPSULES",ASSAY,"USPNF Online",Online,23-Feb-2024,1-Mar-2024,NA,NA,"In Procedure: Change
1000C(RU/RS)
to:
500C(RU/RS)"
"COCOYL CAPRYLOCAPRATE","SPECIFIC TESTS","USPNF Online",Online,23-Feb-2024,1-May-2024,NA,NA,"In Fats and Fixed Oils 〈401〉, Procedures, Hydroxyl Value/Analysis: Change
Calculate the acid value as directed in the chapter.
to:
Calculate the hydroxyl value as directed in the chapter."
"<430> PARTICLE SIZE ANALYSIS BY DYNAMIC LIGHT SCATTERING",GLOSSARY,"USPNF Online",Online,27-Oct-2023,1-May-2024,NA,NA,"In Average particle diameter: Change
expressed in nanometers.
to:
expressed in meters.
AND
In Viscosity: Change
in millipascal-seconds (mPa・s).
to:
in pascal-seconds (Pa・s)."
"<659> PACKAGING AND STORAGE REQUIREMENTS","GENERAL DEFINITIONS/Packaging Definitions","Second Supplement to USP43–NF38",Online,26-Mar-2021,1-Dec-2025,NA,NA,"In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-Resistant Components and Systems."