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PDF CSV March 29, 2022 through March 29, 2024 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
LANSOPRAZOLE DELAYED-RELEASE CAPSULES IMPURITIES/Organic Impurities USPNF Online Online 1-Oct-2022 NA NA Delete
Blank: Methanol and Diluent (1:9)
TERAZOSIN CAPSULES ASSAY/Procedure USPNF Online Online 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 1-Oct-2022 NA NA In Analysis: Change
Calculate the percentage of ceftiofur (C19H17N5O7S3) in the portion of Ceftiofur Hydrochloride taken:
Result = (rU/rS Read More
POTASSIUM GLUCONATE IMPURITIES/Reducing Substances USPNF Online Online 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 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 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 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… Read More
METHYLENE BLUE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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 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 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… Read More
<467> RESIDUAL SOLVENTS USP REFERENCE STANDARDS <11> USPNF Online Online 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 1-Sep-2022 NA NA Change
NTL 90.0% and NMT 110.0%
to:
NLT 90.0% and NMT 110.0%
0.1 M ZINC SULFATE VS STANDARDIZATION USPNF Online Online 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… Read More
ECONAZOLE NITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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.… Read More
<621> CHROMATOGRAPHY ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS USPNF Online Online 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 =… Read More
PROMETHAZINE HYDROCHLORIDE IMPURITIES/Organic Impurities USPNF Online Online 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… Read More
METHYLENE BLUE IMPURITIES/Organic Impurities USPNF Online Online 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.
MELOXICAM ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 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)
LATANOPROST ASSAY/Procedure USPNF Online Online 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:… Read More
FORSKOHLII COMPOSITION/Content of Forskolin USPNF Online Online 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
<871> SUTURES--NEEDLE ATTACHMENT PROCEDURE USPNF Online Online 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 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 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
POWDERED FORSKOHLII EXTRACT COMPOSITION/Content of Forskolin USPNF Online Online 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
AMMONIUM GLYCYRRHIZATE CHEMICAL INFORMATION USPNF Online Online 1-Jul-2022 NA NA Change
840.08
to:
839.97
MELENGESTROL ACETATE CHEMICAL INFORMATION USPNF Online Online 1-Jul-2022 NA NA Change
396.52
to:
396.53
IVERMECTIN CHEMICAL INFORMATION USPNF Online Online 1-Jul-2022 NA NA Change
C48H74O14(Component H2B1a) 875.09
C47H72O14(Component H2B1b) 861.07
Component H2B1a:
Avermectin… Read More
DOXYCYCLINE HYCLATE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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… Read More
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS ASSAY/Procedure USPNF Online Online 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 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 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-… Read More
DOXYCYCLINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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… Read More
MILK THISTLE CAPSULES PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution USPNF Online Online 1-Aug-2022 NA NA In Medium: Change
Buffer containing 2% lauryl sulfate; 900 mL
to:
Buffer containing 2% sodium lauryl sulfate; 900 mL
AMMONIUM GLYCYRRHIZATE ASSAY/Content of Ammonium 18α- and 18β-Glycyrrhizate USPNF Online Online 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… Read More
MELENGESTROL ACETATE USP Reference standards 〈11〉 USPNF Online Online 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-… Read More
DOXYCYCLINE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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… Read More
DOXYCYCLINE HYCLATE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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… Read More
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS IMPURITIES/Limit of Homatropine Hydrobromide and Related Substances USPNF Online Online 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 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 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… Read More
MILK THISTLE TABLETS PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution USPNF Online Online 1-Aug-2022 NA NA In Medium: Change
Buffer containing 2% lauryl sulfate; 900 mL
to:
Buffer containing 2% sodium lauryl sulfate; 900 mL
AMMONIUM GLYCYRRHIZATE SPECIFIC TESTS USPNF Online Online 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 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 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… Read More
ASCORBIC ACID INJECTION ASSAY/Procedure USPNF Online Online 1-Jul-2022 NA NA In Chromatographic system/Column: Change
150-cm × 6-mm; packing L39
to:
15-cm × 6-mm; packing L39
RIFABUTIN CHEMICAL INFORMATION USPNF Online Online 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]… Read More
DOXYCYCLINE HYCLATE CHEMICAL INFORMATION USPNF Online Online 1-Jun-2022 NA NA Change
1025.87
to:
1025.88
FLUOCINOLONE ACETONIDE Organic Impurities USPNF Online Online 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… Read More
NANDROLONE DECANOATE ASSAY/Procedure USPNF Online Online 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 (C28H44O… Read More
IBUPROFEN ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 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 Read More