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PDF CSV March 28, 2022 through March 28, 2024 See all Errata for USP–NF How to use
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<1042> CELL BANKING PRACTICES FOR RECOMBINANT BIOLOGICS 5. CELL BANK CHARACTERIZATION USPNF Online Online 1-May-2023 NA NA In Table 4: Change
In vitro assayd,e + + +f
to:
In vitro assayd,e + −f +
LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION Assay for lidocaine hydrochloride USPNF Online Online 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… Read More
DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION Assay USPNF Online Online 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… Read More
ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION Assay USPNF Online Online 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… Read More
ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION Identification USPNF Online Online 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… Read More
METAPROTERENOL SULFATE TABLETS Identification/A. USPNF Online Online 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… Read More
METAPROTERENOL SULFATE ORAL SOLUTION Identification/A. USPNF Online Online 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… Read More
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
REAGENTS AND REFERENCE TABLES Reagent Specifications/Tosylchloramide Sodium USPNF Online Online 1-Aug-2023 NA NA Change
127-65-1
to:
7080-50-4
MUPIROCIN CREAM Related compounds/Table 1 USPNF Online Online 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:… Read More
MUPIROCIN NASAL OINTMENT Related compounds/Table 1 USPNF Online Online 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:… Read More
REAGENTS AND REFERENCE TABLES Solutions/Test Solutions and Indicator Solutions/Starch TS USPNF Online Online 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… Read More
ONDANSETRON ORAL SOLUTION USP Reference standards <11> USPNF Online Online 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… 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
MECAMYLAMINE HYDROCHLORIDE USP Reference standards <11> USPNF Online Online 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.
C11… Read More
CEFDINIR ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
CEFDINIR CAPSULES ADDITIONAL REQUIREMENTS USPNF Online Online 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
C14H13N4O4S… Read More
CEFDINIR FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS USPNF Online Online 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
C14H13N4O4S… Read More
AZITHROMYCIN ADDITIONAL REQUIREMENTS USPNF Online Online 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
AZITHROMYCIN FOR INJECTION ADDITIONAL REQUIREMENTS USPNF Online Online 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… Read More
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES ADDITIONAL REQUIREMENTS USPNF Online Online 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.
IODIXANOL INJECTION ADDITIONAL REQUIREMENTS USPNF Online Online 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-… Read More
CRANBERRY FRUIT DRY JUICE ADDITIONAL REQUIREMENTS USPNF Online Online 1-Sep-2023 NA NA In USP Reference Standards 〈11〉: Change
USP Procyanidin A2 RS
to:
USP Procyanidin A2 RS
SODIUM SALICYLATE ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA In USP Reference Standards 〈11〉: Add
USP Phenol RS
TETRACYCLINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/Labeling USPNF Online Online 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… 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
DOXYCYCLINE HYCLATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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
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.
CARBAMAZEPINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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
CALCIUM L-5-METHYLTETRAHYDROFOLATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Nov-2022 NA NA Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
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
MESO-ZEAXANTHIN PREPARATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2023 NA NA In USP meso-Zeaxanthin RS: Change
(3R,3′S-meso)-Zeaxanthin.
to:
(3R,3′S)-Zeaxanthin.
PANTOPRAZOLE SODIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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-… 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 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
ONDANSETRON TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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… Read More
MESO-ZEAXANTHIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2023 NA NA In USP meso-Zeaxanthin RS: Change
(3R,3′S-meso)-Zeaxanthin.
to:
(3R,3′S)-Zeaxanthin.
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
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
AZITHROMYCIN FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 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
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
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
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
METARAMINOL BITARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 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.
C9H Read More
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Apr-2023 NA NA Change
USP 2-Methylbenzhydrol RS
to:
USP Methylbenzhydrol RS
TIOCONAZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 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
C16H13BrCl2… Read More
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 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)
METHYLPHENIDATE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 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.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 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.
ATORVASTATIN CALCIUM ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 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… Read More