Skip to main content

Errata - English

PDF CSV March 28, 2022 through March 28, 2024 See all Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
ZIPRASIDONE HYDROCHLORIDE IMPURITIES USPNF Online Online 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… 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
BLACK CUMIN SEED THYMOQUINONE OIL DEFINITION USPNF Online Online 1-Sep-2023 NA NA Change
carvacol
to:
carvacrol
CRANBERRY FRUIT DRY JUICE COMPOSITION USPNF Online Online 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… Read More
ZIPRASIDONE CAPSULES PERFORMANCE TESTS USPNF Online Online 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… 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
AMANTADINE HYDROCHLORIDE IDENTIFICATION USPNF Online Online 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… Read More
CRANBERRY FRUIT DRY JUICE DEFINITION USPNF Online Online 1-Sep-2023 NA NA Change
procyanidin A2
to:
procyanidin A2
OCTOCRYLENE IDENTIFICATION USPNF Online Online 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 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 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 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 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 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 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… Read More
ARIPIPRAZOLE TABLETS PERFORMANCE TESTS USPNF Online Online 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 = (R… Read More
CRANBERRY FRUIT DRY JUICE IDENTIFICATION USPNF Online Online 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… Read More
ZIPRASIDONE CAPSULES ASSAY USPNF Online Online 1-Sep-2023 NA NA In Procedure/Analysis: Change
449.40
to:
449.39
AZITHROMYCIN IMPURITIES USPNF Online Online 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… Read More
TRIMETHOBENZAMIDE HYDROCHLORIDE CHEMICAL INFORMATION USPNF Online Online 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 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… Read More
CLOMIPHENE CITRATE TABLETS IMPURITIES/Organic Impurities USPNF Online Online 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 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-… Read More
AZITHROMYCIN FOR INJECTION IMPURITIES USPNF Online Online 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-… 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
POLYVINYL ALCOHOL IMPURITIES USPNF Online Online 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 =… Read More
<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS SPECIFIC TESTS FOR TDS USPNF Online Online 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… Read More
PIPERACILLIN SPECIFIC TESTS USPNF Online Online 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… Read More
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
TRIAZOLAM TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 1-Aug-2023 NA NA In Standard solution: Change
Tablet/mg
to:
mg/Tablet
ATORVASTATIN CALCIUM TABLETS ASSAY/Procedure USPNF Online Online 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
M… 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)
DIGOXIN TABLETS ASSAY/Procedure USPNF Online Online 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 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… Read More
ATORVASTATIN CALCIUM TABLETS IMPURITIES/Organic Impurities USPNF Online Online 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
M… Read More
ATORVASTATIN CALCIUM TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 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:
Read More
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER IDENTIFICATION/A. USPNF Online Online 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 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 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
ATORVASTATIN CALCIUM TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Jul-2023 NA NA In USP Atorvastatin Related Compound B RS: Change
1155.34
to:
1155.36
CALCIUM ASCORBATE ASSAY/Procedure USPNF Online Online 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
OSELTAMIVIR PHOSPHATE IMPURITIES/Organic Impurities/Procedure 3: Limit Of Tributyl Phosphine Oxide USPNF Online Online 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… Read More
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.
LINEZOLID TABLETS IMPURITIES/Organic Impurities USPNF Online Online 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
CALCIUM ASCORBATE IDENTIFICATION/A. USPNF Online Online 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,… Read More
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.
MILBEMYCIN OXIME CHEMICAL INFORMATION USPNF Online Online 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,… Read More
ATOVAQUONE IMPURITIES USPNF Online Online 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… Read More
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
ESCITALOPRAM TABLETS ASSAY/Procedure USPNF Online Online 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.