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PDF CSV July 24, 2019 through July 24, 2021 See 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
KETOROLAC TROMETHAMINE IMPURITIES/Organic Impurities USP43–NF38 2513 1-Jul-2021 NA NA Change
Mobile phase, Diluent, System suitability solution, Standard solution, and Sample solution: Proceed as directed in the Assay.
to:
Mobile phase, Diluent, System suitability solution, Standard solution, Sample… Read More
BENAZEPRIL HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP References standards <11> USP43–NF38 488 1-Jul-2021 NA NA In USP Benazepril Related Compound A RS: Change
(3R) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
to:
2-[(R)-3-{[(R)-1-Ethoxy-1… Read More
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official March 01, 2021) Online 1-Jul-2021 NA NA In Test 14/Analysis: Delete
Result4 = {(C4 × V) + [(C3 + C2 + C1) × VS]} × (1/L) × 100
LANSOPRAZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 2551 1-Jul-2021 NA NA In USP Lansoprazole Related Compound B RS: Change
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-pyridin-2-yl] methyl]sulfanyl]-1H-benzimidazole.
C16H14F3N3OS 353.36
to:
2-{[(3-Methyl-4-(2,2,2-… Read More
GLYBURIDE CHEMICAL INFORMATION USP43–NF38 2125 1-Jul-2021 NA NA Change
1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohex-ylurea
to:
1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea
NORTRIPTYLINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-Jul-2021 NA NA In USP Amitriptyline Related Compound B RS: Change
295.42
to:
295.43
BENAZEPRIL HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP References Standards <11> USP43–NF38 Online 1-Jul-2021 NA NA In USP Benazepril Related Compound B RS: Change
(3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-… Read More
CLOZAPINE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Jul-2021 NA NA In Table 2: Change
Demethyl clozapin
to:
Demethyl clozapine
DACTINOMYCIN CHEMICAL INFORMATION USP43–NF38 Online 1-Jul-2021 NA NA Please see the updated chemical structure at online.uspnf.com
AMIODARONE HYDROCHLORIDE INJECTION IMPURITIES/Limit of Iodide USP43–NF38 254 1-Jul-2021 NA NA In Potassium iodate solution: Change
10.7 g/L of potassium iodide in water
to:
10.7 g/L of potassium iodate in water
AMITRIPTYLINE HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 263 1-Jul-2021 NA NA In USP Amitriptyline Related Compound B RS: Change
295.42
to:
295.43
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS ADDITIONAL REQUIREMENTS/USP References Standards <11> Revision Bulletin (Official May 01, 2021) Online 1-Jul-2021 NA NA In USP Benazepril Related Compound B RS: Change
(3S) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS… Read More
AMITRIPTYLINE HYDROCHLORIDE CHEMICAL INFORMATION USP43–NF38 Online 1-Jun-2021 NA NA Change
313.86
to:
313.87
CARBOMER INTERPOLYMER IMPURITIES USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A,… Read More
MINOXIDIL TABLETS IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA In Analysis: Change
Result = (rU/rS) × (CU/CS) × 100
to:
Result = (rU/rS) × (CS/CU) × 100
HYDROXYZINE PAMOATE CAPSULES ASSAY/Procedure USP43–NF38 2271 1-Jun-2021 NA NA In System suitability/Suitability requirements/Resolution: Change
4-chlorobenophenone,
to:
4-chlorobenzophenone,
CARBOMER HOMOPOLYMER IMPURITIES USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A,… Read More
CLOZAPINE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA Change
326.82
to:
326.83
AMITRIPTYLINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 Online 1-Jun-2021 NA NA In USP Amitriptyline Related Compound B RS: Change
295.42
to:
295.43
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS ASSAY/Procedure USP43–NF38 938 1-Jun-2021 NA NA In Analysis: Change
313.86
to:
313.87
GARLIC FLUIDEXTRACT COMPOSITION/Content of S-Allyl-L-cysteine USP43–NF38 5023 1-Jun-2021 NA NA In Analysis: Change
Calculate the percentage of S-allyl-L-cysteine (C6H11SN) in the portion of Fluidextract taken:
to:
Calculate the percentage of S-allyl-L-cysteine in the portion of Fluidextract taken:
HYDROXYZINE PAMOATE IMPURITIES/Organic Impurities USP43–NF38 2269 1-Jun-2021 NA NA In System suitability/Suitability requirements/Resolution: Change
4-chlorobenophenone
to:
4-chlorobenzophenone
CARBOMER HOMOPOLYMER CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA Please see the updated chemical structure at https://online.uspnf.com
GADOTERATE MEGLUMINE INJECTION OTHER COMPONENTS/Content of Meglumine USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA In Analysis: Change
Result = (a/α) × (1/l) × (1/L) × 100
to:
Result = (a/α) × 100 × (1/l) × (1/L) × 100
CARBOMER COPOLYMER IMPURITIES USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA In Limit of Ethyl Acetate and Cyclohexane/Analysis: Change
Samples: Standard stock solution, Standard solution A, Standard solution B, Standard solution C, and Sample solution
to:
Samples: Standard solution A,… Read More
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 938 1-Jun-2021 NA NA In Analysis: Change
313.86
to:
313.87
BIFIDOBACTERIUM LONGUM SUBSP. LONGUM DEFINITION USPNF 2021 ISSUE 1 Online 1-Jun-2021 NA NA Change
Bifidobacteriumlongum subsp. longum comprises
to:
Bifidobacterium longum subsp. longum comprises
AZITHROMYCIN FOR ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Medium: Change
Sodium phosphate buffer, pH of 6.0 (14.2 g/L of disodium hydrogen orthophosphate anhydrous in water, adjusted with dilute hydrochloric acid to a pH of 6.0)
to:
Sodium phosphate buffer, pH 6.0 (14.2 g/L of sodium… Read More
MALTITOL SOLUTION IMPURITIES/Limit of Nickel USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
Solution A: [Note—Prepare this solution fresh weekly.]
to:
Standard nickel solution A: [Note—Prepare this solution fresh weekly.]
CARBOMER INTERPOLYMER IMPURITIES/Limit of Acrylic Acid USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Analysis: Change
CU = concentration of Carbomer Interpolymer in the Sample solution (g)
to:
CU = concentration of Carbomer Interpolymer in the Sample solution (mg/g)
AZITHROMYCIN FOR ORAL SUSPENSION ASSAY/Procedure USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Solution A: Change
orthophosphoric acid
to:
phosphoric acid
CARBOPROST TROMETHAMINE CHEMICAL INFORMATION USP43–NF38 771 1-May-2021 NA NA Change
489.64
to:
489.65
AND
Change
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(E)-(3S)-3-hydroxy-3-methyl-1-octenyl]cyclopentyl]-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CHEWABLE GELS STRENGTH USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Vitamins B3 (as Niacinamide), B6, and Folic Acid, Method 1/System suitability: Change
[Note—The relative retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 1.6, 2.0, and 3.0 respectively.]
to:
[Note—The relative… Read More
CARBOMER INTERPOLYMER CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Please see the updated chemical structure at online.uspnf.com
DOXEPIN HYDROCHLORIDE CAPSULES PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official May 01, 2021) Online 1-May-2021 NA NA In Test 1/Analysis: Change
L = label claim of doxepin hydrochloride (mg/Capsule)
to:
L = label claim (mg/Capsule)
AMPICILLIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 316 1-Apr-2021 NA NA In USP Amoxicillin Related Compound A RS: Change
(2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
C16H14N2O2 266.29
to:
(2S… Read More
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS IMPURITIES/Organic Impurities USP43–NF38 4519 1-Apr-2021 NA NA In Sample solution: Change
Nominally 1 mg/mL of trihexyphenidyl hydrochloride in Diluent prepared as follows.
to:
Nominally 1 mg/mL of trihexyphenidyl hydrochloride prepared as follows.
RILUZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 3882 1-Apr-2021 NA NA In USP Riluzole Related Compound A RS: Change
4-Trifluoromethoxyphenylamine; 4-trifluoromethoxyanaline.
C7H6F3NO 177.12
to:
4-(Trifluoromethoxy)aniline.
C7H6F3NO… Read More
MIRTAZAPINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 Online 1-Apr-2021 NA NA In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the… Read More
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS/Packaging Definitions Second Supplement to USP43–NF38 Online 1-Apr-2021 NA NA In Light-resistant container: Change
〈671〉, Spectral Transmission
to:
〈671〉, Spectral Transmission for Light-Resistant Packaging Components or Systems
NADOLOL AND BENDROFLUMETHIAZIDE TABLETS IMPURITIES USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Organic Impurities, Procedure 2: Bendroflumethiazide Related Impurities/Acceptance criteria: Change
The reporting threshold is NMT 0.05%.
to:
The reporting threshold is 0.05%.
ZILEUTON USP Reference standards <11> USP43–NF38 4679 1-Apr-2021 NA NA In USP Zileuton Related Compound A RS: Change
N-(1-Benzo-[b]thien-2-ylethyl)urea.
C11H12N2OS 220.30
to:
N-(1-Benzo-[b]thien-2-ylethyl)urea;
Also known as 1… Read More
SERTRALINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In USP Sertraline Hydrochloride Racemic Mixture RS: Change
C17H17Cl2 · HCl
to:
C17H17Cl2N · HCl
RILUZOLE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 3883 1-Apr-2021 NA NA In USP Riluzole Related Compound A RS: Change
4-Trifluoromethoxyaniline.
C7H6F3NO 177.12
to:
4-(Trifluoromethoxy)aniline.
C7H6F3NO 177.13
MIRTAZAPINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 Online 1-Apr-2021 NA NA In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the… Read More
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS/Packaging Definitions Second Supplement to USP43–NF38 Online 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-… Read More
GENERAL NOTICES AND REQUIREMENTS 2. OFFICIAL STATUS AND LEGAL RECOGNITION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In 2.10. Official Text: Change
http://www.uspnf.com.
to:
https://online.uspnf.com.
CARBOMER COPOLYMER CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA See online.uspnf.com for correction
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 2128 1-Apr-2021 NA NA In USP Glyburide Related Compound A RS: Change
368.84
to:
368.83
FENTANYL CITRATE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In both variable definition lists in Analysis: Change
Mr1 = molecular weight of fentanyl citrate, 528.59
Mr2 = molecular weight of fentanyl, 336.47
to:
Mr1 =… Read More