Monograph Title | Section | Source Publication | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
PINDOLOL | ASSAY/Procedure | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | In Standard stock solution: Change 1 mg/mL of USP Pindolol RS in Mobile phase prepared as follows. To a suitable amount of USP Pindolol RS add Mobile phase to fill about 90% of the total volume, and sonicate for about 5 min to… Read More |
POLYETHYLENE GLYCOL 12 CETOSTEARYL ETHER | IDENTIFICATION | USPNF Online | Online | 28-Apr-2023 | 1-Aug-2023 | NA | NA | Change: B. Test for Hydroxyl Group: to: B. Hydroxyl Value: AND In D./Analysis: Change Dissolve or disperse the Sample in alcohol. to: Dissolve or disperse the … Read More |
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES | IDENTIFICATION | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | Change A. The UV-Vis spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. to: A. The UV spectrum of the major peak of the Sample solution… Read More |
FLUTICASONE PROPIONATE NASAL SPRAY | OTHER COMPONENTS/Content of Phenylethyl Alcohol | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | In Sample solution: Change Transfer 1.0 g of the Nasal Spray to a 50-mL volumetric flask. Add about 40 mL of Diluent, and sonicate for 10 min until the supernatant is clear. Use the clear supernatant for analysis. to: Transfer 1.0 g of the… Read More |
ESCITALOPRAM TABLETS | ASSAY/Procedure | USPNF Online | Online | 28-Apr-2023 | 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. |
ESCITALOPRAM TABLETS | PERFORMANCE TESTS/Dissolution 〈711〉 | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | In Test 1/Medium: Change 0.1 N hydrochloric acid VS; 900 mL to: 0.1 N hydrochloric acid; 900 mL AND In Test 2/Medium: Change 0.1 N hydrochloric acid VS; 900 mL to: 0.1 N hydrochloric acid; 900 mL |
VIGABATRIN TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | In Analysis: Change CS = concentration of USP Vigabatrin Related Compound A in the Standard solution to: CS = concentration of USP Vigabatrin Related Compound A RS in the Standard solution |
FLUVOXAMINE MALEATE TABLETS | ASSAY/Procedure | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | In Solution A: Change 8 g/L of 1-pentanesulfonic acid sodium salt and 1 g/L of monobasic potassium phosphate in water. to: 8 g/L of 1-pentanesulfonic acid sodium salt and 1.1 g/L of monobasic potassium phosphate in water. |
PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS | PERFORMANCE TESTS | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | Change Uniformity of Dosage Units 〈905〉 Procedure for content uniformity to: Uniformity of Dosage Units 〈905〉: Meets the requirements Procedure for content uniformity, chewable tablets only AND In … Read More |
OSELTAMIVIR PHOSPHATE | IMPURITIES/Organic Impurities/Procedure 3: Limit Of Tributyl Phosphine Oxide | USPNF Online | Online | 26-May-2023 | 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 |
CALCIUM ASCORBATE | IDENTIFICATION/A. | USPNF Online | Online | 26-May-2023 | 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 |
ATOVAQUONE | IMPURITIES | USPNF Online | Online | 26-May-2023 | 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 |
LINEZOLID TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 26-May-2023 | 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 |
MILBEMYCIN OXIME | CHEMICAL INFORMATION | USPNF Online | Online | 26-May-2023 | 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 |
METHYLPHENIDATE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 | USPNF Online | Online | 26-May-2023 | 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 | 26-May-2023 | 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 | 26-May-2023 | 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 |
DIGOXIN TABLETS | ASSAY/Procedure | USPNF Online | Online | 30-Jun-2023 | 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 |
SITAGLIPTIN PHOSPHATE | IMPURITIES/Organic Impurities | USPNF Online | Online | 30-Jun-2023 | 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) |
ATORVASTATIN CALCIUM TABLETS | ASSAY/Procedure | USPNF Online | Online | 30-Jun-2023 | 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 | 30-Jun-2023 | 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 |
ATORVASTATIN CALCIUM TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 | USPNF Online | Online | 30-Jun-2023 | 1-Jul-2023 | NA | NA | In USP Atorvastatin Related Compound B RS: Change 1155.34 to: 1155.36 |
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution 〈711〉 | USPNF Online | Online | 30-Jun-2023 | 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 |
TIOCONAZOLE | ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 | USPNF Online | Online | 30-Jun-2023 | 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 | 30-Jun-2023 | 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) |
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER | IDENTIFICATION/A. | USPNF Online | Online | 30-Jun-2023 | 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) |
CALCIUM ASCORBATE | ASSAY/Procedure | USPNF Online | Online | 30-Jun-2023 | 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 |
ATORVASTATIN CALCIUM TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 30-Jun-2023 | 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 |
<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 |
PURIFIED SILICEOUS EARTH | IMPURITIES | USPNF Online | Online | 28-Jul-2023 | 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 |
REAGENTS AND REFERENCE TABLES | Reagent Specifications/Tosylchloramide Sodium | USPNF Online | Online | 28-Jul-2023 | 1-Aug-2023 | NA | NA | Change 127-65-1 to: 7080-50-4 |
TRIAZOLAM TABLETS | PERFORMANCE TESTS/Dissolution 〈711〉 | USPNF Online | Online | 28-Jul-2023 | 1-Aug-2023 | NA | NA | In Standard solution: Change Tablet/mg to: mg/Tablet |
CHLORTETRACYCLINE HYDROCHLORIDE | CHEMICAL INFORMATION | USPNF Online | Online | 28-Jul-2023 | 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 |
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 |
CLOMIPHENE CITRATE TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 28-Jul-2023 | 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 |
POLYVINYL ALCOHOL | IMPURITIES | USPNF Online | Online | 28-Jul-2023 | 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 |
TRIMETHOBENZAMIDE HYDROCHLORIDE | CHEMICAL INFORMATION | USPNF Online | Online | 28-Jul-2023 | 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 |
AZITHROMYCIN FOR INJECTION | IMPURITIES | USPNF Online | Online | 28-Jul-2023 | 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 |
AZITHROMYCIN FOR INJECTION | ADDITIONAL REQUIREMENTS | USPNF Online | Online | 28-Jul-2023 | 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 |
REAGENTS AND REFERENCE TABLES | Solutions/Test Solutions and Indicator Solutions/Starch TS | USPNF Online | Online | 25-Aug-2023 | 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 |
UREA C 13 | IMPURITIES | USPNF Online | Online | 25-Aug-2023 | 1-Sep-2023 | NA | NA | In Isotopic Purity/Chromatographic system: Change Flow rate: Flow rate to: Flow rate: 1 mL/min |
DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | Assay | USPNF Online | Online | 25-Aug-2023 | 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 |
AMANTADINE HYDROCHLORIDE | IDENTIFICATION | USPNF Online | Online | 25-Aug-2023 | 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 |
ARIPIPRAZOLE TABLETS | PERFORMANCE TESTS | USPNF Online | Online | 25-Aug-2023 | 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 |
BLACK CUMIN SEED THYMOQUINONE OIL | DEFINITION | USPNF Online | Online | 25-Aug-2023 | 1-Sep-2023 | NA | NA | Change carvacol to: carvacrol |
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 |
SODIUM ALGINATE | ASSAY | USPNF Online | Online | 25-Aug-2023 | 1-Sep-2023 | NA | NA | In Procedure/Analysis: Change Result = (V2 × N × WE)/(W × D) to: Result = (V2 × N × WE × 10)/(W × D) |
CRANBERRY FRUIT DRY JUICE | DEFINITION | USPNF Online | Online | 25-Aug-2023 | 1-Sep-2023 | NA | NA | Change procyanidin A2 to: procyanidin A2 |
CRANBERRY FRUIT DRY JUICE | IDENTIFICATION | USPNF Online | Online | 25-Aug-2023 | 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 |
CRANBERRY FRUIT DRY JUICE | COMPOSITION | USPNF Online | Online | 25-Aug-2023 | 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 |