Monograph Title | Section | Source Publication | Page Number Sort descending | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
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FLUOCINOLONE ACETONIDE | Organic Impurities | USPNF Online | Online | 27-May-2022 | 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 |
TRYPTOPHAN | ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 | USPNF Online | Online | 24-Jun-2022 | 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 |
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 |
MESO-ZEAXANTHIN PREPARATION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF Online | Online | 27-Jan-2023 | 1-Feb-2023 | NA | NA | In USP meso-Zeaxanthin RS: Change (3R,3′S-meso)-Zeaxanthin. to: (3R,3′S)-Zeaxanthin. |
DEXTRATES | ASSAY/Dextrose Equivalent | USPNF Online | Online | 31-Mar-2023 | 1-May-2023 | NA | NA | In Analysis: Change rA = peak response of each saccharide degree of polymerization (DP1–DP3) in the Sample solution (If any peaks of DP4 and above are observed in the sample, take the summation… Read More |
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 |
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 |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES | PERFORMANCE TESTS | USPNF Online | Online | 17-Nov-2023 | 1-Dec-2023 | NA | NA | In Dissolution 〈711〉/Test for dutasteride/Tier 2/Medium: Change 10 g/L of cetyltrimethylammonium bromide and 750,000 USP units of activity/mg of pepsin, purified in 0.1 N hydrochloric acid; 900 mL to: Dissolve 10 g of… Read More |
<1228.1> DRY HEAT DEPYROGENATION | INTRODUCTION | USPNF Online | Online | 23-Feb-2024 | 1-Mar-2024 | NA | NA | Change parental manufacturing to: parenteral manufacturing |
ATRACURIUM BESYLATE | CHEMICAL INFORMATION | USPNF Online | Online | 27-May-2022 | 1-Jun-2022 | NA | NA | Change 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester to: 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate,… Read More |
IRINOTECAN HYDROCHLORIDE INJECTION | DEFINITION | USPNF Online | Online | 26-Aug-2022 | 1-Sep-2022 | NA | NA | Change NTL 90.0% and NMT 110.0% to: NLT 90.0% and NMT 110.0% |
DOXAZOSIN MESYLATE | IMPURITIES/Organic Impurities | USPNF Online | Online | 28-Oct-2022 | 1-Nov-2022 | NA | NA | In Analysis: Change CS = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL) to: CS… Read More |
ISOBUTYL ALCOHOL | ASSAY/Procedure | USPNF Online | Online | 27-Jan-2023 | 1-Feb-2023 | NA | NA | In Analysis: Change rS = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution to: rT = sum of all the peaks except those… Read More |
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS | ASSAY | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | Delete [Note—Use a non-metallic liquid chromatography system for analysis.] |
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 |
AZITHROMYCIN | ADDITIONAL REQUIREMENTS | USPNF Online | Online | 25-Aug-2023 | 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 |
<81> ANTIBIOTICS—MICROBIAL ASSAYS | APPENDICES | USPNF Online | Online | 29-Dec-2023 | 1-Jan-2024 | NA | NA | In two instances in Appendix 1 equations: Change 14.020 to: 14.022 |
DACARBAZINE FOR INJECTION | IMPURITIES | USPNF Online | Online | 29-Apr-2022 | 1-May-2022 | NA | NA | Delete Limit of 2-Azahypoxanthine test |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS | ASSAY/Procedure | USPNF Online | Online | 24-Jun-2022 | 1-Jul-2022 | NA | NA | In Buffer: Change Adjust with phosphoric acid to a pH of 6.4 ± 0.01. to: Adjust with phosphoric acid to a pH of 6.4 ± 0.1. |
SODIUM PICOSULFATE | IMPURITIES/Organic Impurities | USPNF Online | Online | 30-Sep-2022 | 1-Oct-2022 | NA | NA | In Buffer: Change cetylrimethylammonium bromide, to: cetyltrimethylammonium bromide, |
MOMETASONE FUROATE TOPICAL SOLUTION | IDENTIFICATION | USPNF Online | Online | 18-Nov-2022 | 1-Dec-2022 | NA | NA | In test A: Change The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay. to: The retention time of the major… Read More |
MIRTAZAPINE TABLETS | IMPURITIES/Organic Impurities | USPNF Online | Online | 24-Feb-2023 | 1-Mar-2023 | NA | NA | In System suitability/Suitability requirements/Resolution: Change 10-ketomirtazpine to: 10-ketomirtazapine AND In Table 1: Change 1-Ketomirtazpinec to: 1-Ketomirtazapinec |
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 |
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 |
AMOXICILLIN FOR INJECTABLE SUSPENSION | Identification | USPNF Online | Online | 27-Oct-2023 | 1-Nov-2023 | NA | NA | Change Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification… Read More |
IODIXANOL INJECTION | IMPURITIES | USPNF Online | Online | 23-Feb-2024 | 1-Mar-2024 | NA | NA | In Organic Impurities, Procedure 2/footnote 4: Change 5-[[3-[[3-[[[3-[[3-[[3,5-Bis-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl](acetylimino)]-2-hydroxypropyl](acetylimino)]-5-[[[2,3-dihydroxypropyl]amino]carbonyl]-2,4,6-triiodophenyl]carbonyl]amino]-2-hy… Read More |
DIMENHYDRINATE TABLETS | OTHER COMPONENTS/8-Chlorotheophylline | USPNF Online | Online | 27-May-2022 | 1-Jun-2022 | NA | NA | In Analysis: Change CU = nominal concentration of dimenhydrinate in the Sample solution (mg/mL) to: CU = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay… Read More |
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 |
TETRACYCLINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/Labeling | USPNF Online | Online | 28-Oct-2022 | 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 |
MESO-ZEAXANTHIN | CHEMICAL INFORMATION | USPNF Online | Online | 27-Jan-2023 | 1-Jun-2023 | NA | NA | Change (3R,3′S-meso)-Zeaxanthin to: (3R,3′S)-Zeaxanthin |
PRAZOSIN HYDROCHLORIDE CAPSULES | ASSAY/Procedure | USPNF Online | Online | 31-Mar-2023 | 1-Apr-2023 | NA | NA | In Analysis: Change CS = concentration of USP Prazosin Hydrochloride RS in the Standard solution (µg/mL) CU = nominal concentration of prazosin in the Sample solution (µg/mL) Mr1… 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 |
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 |
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES | ADDITIONAL REQUIREMENTS | USPNF Online | Online | 17-Nov-2023 | 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. |
ENSULIZOLE | IDENTIFICATION | USPNF Online | Online | 29-Mar-2024 | 1-Apr-2024 | NA | NA | In B.: Change The retention time of the major peak of the Sample solution exhibits maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay. to: The retention time of the major… Read More |
IVERMECTIN | CHEMICAL INFORMATION | USPNF Online | Online | 24-Jun-2022 | 1-Jul-2022 | NA | NA | Change C48H74O14(Component H2B1a) 875.09 C47H72O14(Component H2B1b) 861.07 Component H2B1a: Avermectin… Read More |
POTASSIUM GLUCONATE | IMPURITIES/Reducing Substances | USPNF Online | Online | 26-Aug-2022 | 1-Sep-2022 | NA | NA | In Titrimetric system: Change Titrant: Iodine Back-titrant: Sodium thiosulfate to: Titrant: 0.1 N Iodine VS Back-titrant: 0.1 N Sodium Thiosulfate VS |
CALCIUM UNDECYLENATE | ASSAY/Procedure | USPNF Online | Online | 28-Oct-2022 | 1-Nov-2022 | NA | NA | In Solution A: Change 0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well. to: 0.15 N hydrochloric acid in water prepared as follows.… Read More |
POLYETHYLENE GLYCOL STANDARDS WITH MOLECULAR WEIGHTS OF 1000, 2000, 3000, 4000, AND 6000 DALTONS (G/MOL) | CHEMICAL INFORMATION | USPNF Online | Online | 27-Jan-2023 | 1-Feb-2023 | NA | NA | Change CAS RN®: 25332-68-3. to: CAS RN®: 25322-68-3. |
ACARBOSE TABLETS | IDENTIFICATION/B. | USPNF Online | Online | 28-Apr-2023 | 1-May-2023 | NA | NA | Change The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1. to: The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200… 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 |
VALGANCICLOVIR HYDROCHLORIDE | IMPURITIES | USPNF Online | Online | 25-Aug-2023 | 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 |
ACARBOSE | IMPURITIES | USPNF Online | Online | 29-Dec-2023 | 1-Jan-2024 | NA | NA | In Chromatographic Purity/Analysis: Change Result = (rU/rA) × (1/F) × 100 to: Result = (rU/rA) × (1/F) |
MUPIROCIN CREAM | Related compounds/Table 1 | USPNF Online | Online | 29-Apr-2022 | 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 |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS | IMPURITIES/Limit of Homatropine Hydrobromide and Related Substances | USPNF Online | Online | 24-Jun-2022 | 1-Jul-2022 | NA | NA | In Buffer: Change Adjust with phosphoric acid to a pH of 6.4 ± 0.01. to: Adjust with phosphoric acid to a pH of 6.4 ± 0.1. |
TERAZOSIN CAPSULES | ASSAY/Procedure | USPNF Online | Online | 30-Sep-2022 | 1-Oct-2022 | NA | NA | In Hydrochloric acid solution: Change 0.1 N methanolic hydrochloric acid to: 0.01 N methanolic hydrochloric acid |
ROCURONIUM BROMIDE | CHEMICAL INFORMATION | USPNF Online | Online | 18-Nov-2022 | 1-Dec-2022 | NA | USPNF 2023 Issue 3 | Change 609.68 to: 609.69 |
LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION | Assay for lidocaine hydrochloride | USPNF Online | Online | 24-Feb-2023 | 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 |
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. |
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 |