Errata - English

PDF CSV May 14, 2022 through May 14, 2024 See all Errata for USP–NF How to use

Monograph Title	Section Sort descending	Source Publication	Page Number	Errata Post Date	Errata Official Date	Target Errata Print Publication	Target Online Fix Publication	Description
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).
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.
<251> LEAD	REQUIREMENTS FOR PROCEDURE VALIDATION	USPNF Online	Online	27-Jan-2023	1-Jun-2023	NA	NA	Change • Precision Repeatability to: • Precision
BROMPHENIRAMINE MALEATE	SPECIFIC TESTS	USPNF Online	Online	26-Apr-2024	1-May-2024	NA	NA	Change Optical Rotation 〈781〉 to: Optical Rotation, Angular Rotation 〈781A〉
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
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… Read More PIPERACILLIN 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.
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… Read More UREA 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.
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
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:
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.
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
<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… Read More <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 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.
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… Read More TETRACYCLINE HYDROCHLORIDE 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.
METARAMINOL BITARTRATE	SPECIFIC TESTS/Content of Tartaric Acid	USPNF Online	Online	27-Jan-2023	1-Feb-2023	NA	NA	In Analysis: Change Result = {[(V_S−V_B) × N × F]/2 × W} × 100 to: Result = {[(V_S−V_B) × N × F]/(2 × W)} × 100
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… Read More 0.1 M ZINC SULFATE VS 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
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
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 C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL) to: C_S = concentration… Read More OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES In Vitamin A, Method 3/Analysis: Change C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL) to: C_S = concentration of retinyl acetate (C₂₂H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)
OIL-SOLUBLE VITAMINS CAPSULES	STRENGTH	USPNF Online	Online	27-Oct-2023	1-Nov-2023	NA	NA	In Vitamin A, Method 3/Analysis: Change C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL) to: C_S = concentration… Read More OIL-SOLUBLE VITAMINS CAPSULES In Vitamin A, Method 3/Analysis: Change C_S = concentration of retinyl acetate (C₂₃H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL) to: C_S = concentration of retinyl acetate (C₂₂H₃₂O₂) from USP Vitamin A RS in the Standard solution (μg/mL)
<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
<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
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.