Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
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ISOSORBIDE DINITRATE EXTENDED-RELEASE TABLETS | Dissolution <711> | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | In Test 2: Change Determine the amount of isosorbide dinitrate (C6H9NO6) dissolved by employing the following method. to: Determine the amount of isosorbide dinitrate (C6H8N2O… Read More |
APREPITANT CAPSULES | PERFORMANCE TESTS/Dissolution <711> | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | In Test 1/Apparatus 2: Change [Note—A suitable sinker is available from VanKel, www.chem.agilent.com, catalog number 12-3050. Proper placement of the Capsules is in the sinkers with the cap facing the fixed prong… Read More |
ISOPROTERENOL HYDROCHLORIDE INJECTION | Color and clarity | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | Change Using the Injection as the Test solution, proceed as directed for Color and clarity under Isoproterenol Inhalation Solution. to: Standard solution—Transfer 2.0 mL of 0.100 N iodine VS to a 500-mL volumetric flask,… Read More |
ELEUTHERO ROOT AND RHIZOME POWDER | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | Change USP Eleutheroside B RS β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl. C17H24O9 372.37 USP Eleutheroside E RS β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-… Read More |
DACARBAZINE | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | In System suitability/Suitability requirements/Signal-to-noise ratio: Change NTL 10 to: NLT 10 |
CARBOMER INTERPOLYMER | IMPURITIES/Limit of Benzene | USPNF 2021 ISSUE 2 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | In Analysis: Change WU = weight of Carbomer Interpolymer in the Sample solution (mg) to: WU = weight of Carbomer Interpolymer in the Sample solution (μg) |
CEFTIOFUR HYDROCHLORIDE | IMPURITIES/Low Molecular Weight Impurities | USPNF 2021 ISSUE 1 | Online | 19-Nov-2021 | 1-Dec-2021 | NA | NA | In Analysis: Change Result = {rU/[rS + (ΣrU/F)]} × (1/F) × 100 to: Result = {rU/[rS + Σ(rU/F)]} × (1/F) ×… Read More |
DOXAZOSIN MESYLATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF 2021 ISSUE 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In USP Doxazosin Related Compound D RS: Change 1,4-Benzodioxane-2-carboxylic acid. C9H8O5 196.16 to: 1,4-Benzodioxane-2-carboxylic acid. C9H8O4 180.16 |
ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION | SPECIFIC TESTS/Water/Analysis | USPNF2021 Issue 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | Change Result = [(C/V)/W] × 100 to: Result = [(C × V)/W] × 100 |
TIAGABINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF 2021 ISSUE 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In USP Tiagabine Hydrochloride RS: Delete [NOTE—Available in monohydrate form.] |
DIMENHYDRINATE ORAL SOLUTION | Content of 8-chlorotheophylline | USPNF 2021 ISSUE 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | Change Ammonium bicarbonate solution, Diluent, Solution A, Solution B, Mobile phase, Internal standard solution, and Chromatographic system—Proceed as directed in the Assay under Dimenhydrinate Tablets. to: Ammonium… Read More |
DOXAZOSIN MESYLATE | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In Table 2: Change Doxazosin related compound Dg 0.83, 196.16, 196.16, 0.25 to: Doxazosin related compound Dg 0.83, 180.16, 180.16, 0.25 |
<561> ARTICLES OF BOTANICAL ORIGIN | PESTICIDE RESIDUE ANALYSIS/Limits | USPNF2021 Issue 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In Qualitative and Quantitative Analysis of Pesticide Residues: Change [Note—Current version Document No. SANTE/11813/2017, https://ec.europa.eu/food/… Read More |
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In Analysis: Change rS = peak response of alfuzosin from the Sample solution to: rS = peak response of alfuzosin from the Standard solution |
DIMENHYDRINATE ORAL SOLUTION | Assay | USPNF 2021 Issue 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | Change Ammonium bicarbonate solution, Diluent, Solution A, Solution B, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Proceed as directed in the Assay under Dimenhydrinate Tablets… Read More |
PAROXETINE HYDROCHLORIDE | CHEMICAL INFORMATION | Interim Revision Announcement (Official May 01, 2021) | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | Change (−)-(3S,4R)-4-(p-Fluorophenyl)-3-[(3,4-methylenedioxy)phenoxy]methyl]piperidine hydrochloride; to: (−)-(3S,4R)-4-(p-Fluorophenyl)-3-[[(3,4-methylenedioxy)phenoxy]methyl]piperidine hydrochloride; |
SACCHARIN | SPECIFIC TESTS/Readily Carbonizable Substances Test <271> | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Matching fluid A: Change Cobaltous chloride CS, ferric chloride TS, cupric sulfate CS, and water (0.1:0.4:0.1:4.4) to: Cobaltous chloride CS, ferric chloride CS, cupric sulfate CS, and water (0.1:0.4:0.1:4.4) |
GLYBURIDE TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In USP Glyburide Related Compound A RS: Change 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]ben zenesulfonamide. to: 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonamide. |
ACETAMINOPHEN TABLETS | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Chromatographic system/Detector: Change UV 272 nm. For Identification B, use a diode array detector in the range of 200–400 nm. to: UV 272 nm |
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL | 1. OVERVIEW: GENERAL CHAPTERS BASED ON SCATTERING PHENOMENA | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Table 1: Change 〈1430.6〉a to: 〈1430.6〉 AND Change 〈1430.7〉a to: 〈1430.7〉 AND Delete footnote a |
<1788.1> LIGHT OBSCURATION METHOD FOR THE DETERMINATION OF SUBVISIBLE PARTICULATE MATTER | APPENDIX/Particle Count Accuracy Manual Method Test for MWHC Instruments | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Overview: Change The test is also sensitive to size accuracy at 15 μm, since small errors in size will translate into large errors in count at the midpoint of the PS distribution. to: The test is also sensitive to size accuracy at 15 μm, since… Read More |
HYDROXYETHYL CELLULOSE | IMPURITIES/Aldehydes | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Analysis: Change To 2.0 mL of the Sample solution, add 5.0 mL of a 4-g/L solution of methylbenzothiazolone hydrazone hydrochloride to an 80% (v/v) solution of glacial acetic acid in water. to: To 2.0 mL of the Sample solution,… Read More |
OFLOXACIN | CHEMICAL INFORMATION | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | Change (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-l-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid to: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-… Read More |
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-GENERAL | 2. INTRODUCTION | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In paragraph five: Change Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉1 to: Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉 AND In footnote 1: Change This… Read More |
PYRANTEL PAMOATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USPNF 2021 ISSUE 2 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In USP Pyrantel Related Compound A RS: Change (Z)-1-Methyl-2-(2-(thiophen-2-yl)vinyl)-1,4,5,6-tetrahydropyrimidine. C34H30N2O6S 594.69 to: (Z)-1-Methyl-2-[2-(2-thiophenyl)vinyl]-1,4,5,6-… Read More |
RIFABUTIN | IMPURITIES/Organic Impurities, Procedure 2 | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In Sample solution: Change 1 mg/mL of USP Rifabutin RS prepared as follows. to: 1 mg/mL of Rifabutin prepared as follows. |
<197> SPECTROSCOPIC IDENTIFICATION TESTS | EQUIVALENT/ALTERNATIVE TESTS | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change (see Mass Spectrometry 〈736〉, Nuclear Magnetic Resonance Spectroscopy 〈761〉, 〈854〉, 〈857〉, 〈941〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and 〈858〉. to: (see Mass Spectrometry 〈736〉, Nuclear… Read More |
QUETIAPINE EXTENDED-RELEASE TABLETS | IMPURITIES/Organic Impurities/System Suitability | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In Resolution: Change NLT 2.0 between the quetiapine desthoxy and quetiapine peaks to: NLT 2.0 between the quetiapine desethoxy and quetiapine peaks |
DICLOFENAC POTASSIUM | IDENTIFICATION/C. | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In Sample solution: Change 7 N hydrochloride acid to: 7 N hydrochloric acid |
〈197〉 SPECTROSCOPIC IDENTIFICATION TESTS | INTRODUCTION AND SCOPE | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change (see Mid-Infrared Spectroscopy 〈854〉, Ultraviolet-Visible Spectroscopy 〈857〉, X-Ray Powder Diffraction 〈941〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and Raman Spectroscopy 〈858〉. to: (see … Read More |
〈1051〉 CLEANING GLASS APPARATUS | CLEANING VALIDATION BEST PRACTICES | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In Table 2: Change and verify levels are below Loss on Drying 〈731〉. to: and verify levels are below limit of detection. |
〈643〉 TOTAL ORGANIC CARBON | PROCEDURES | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In 1. Bulk Water/1.10 System suitability: Change rE = 100 × [(rC/rL) to: rE = 100 × (rC/rL) |
TACROLIMUS | ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In USP Tacrolimus Related Compound A RS: Change 792.01 to: 792.02 AND In USP Tacrolimus 8-epimer RS: Change 804.02 to: 804.03 |
CETIRIZINE HYDROCHLORIDE | IMPURITIES/Residue on Ignition 〈281〉 | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Delete Sample: 1 g |
<197> SPECTROSCOPIC IDENTIFICATION TESTS | NEAR-INFRARED AND RAMAN SPECTROSCOPY | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change (see Near-Infrared Spectroscopy—Theory and Practice 〈1856〉), to: (see 〈856〉), AND Change (see Chemometrics 〈1039〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and Raman Spectroscopy—Theory and Practice… Read More |
QUETIAPINE EXTENDED-RELEASE TABLETS | ASSAY/Procedure/System Suitability | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | In Resolution: Change NLT 2.0 between the quetiapine desthoxy and quetiapine peaks; System suitability solution to: NLT 2.0 between the quetiapine desethoxy and quetiapine peaks; System suitability solution |
DIMENHYDRINATE INJECTION | Assay | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change Solution A, Solution B, Mobile phase, Internal standard solution, and Chromatographic system—Prepare as directed in the Assay under Dimenhydrinate Tablets. to: Solution A—Dissolve 0.8 g of ammonium… Read More |
ALCOHOLOMETRIC TABLE | INTRODUCTION | USPNF 2021 ISSUE 3 | Online | 27-Aug-2021 | 1-Dec-2021 | NA | NA | Change Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that contains 95% alcohol by weight or 92.42% alcohol v/v. to: Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that… Read More |
LUMEFANTRINE | CHEMICAL INFORMATION | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change (±)-2,7-Dichloro-9-[(Z)-p-chlorobenzylidine]-α[(dibutylamino)methyl]-fluorene-4-methanol to: (±)-2,7-Dichloro-9-[(Z)-p-chlorobenzylidene]-α-[(dibutylamino)methyl]-fluorene-4-methanol |
ZIPRASIDONE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 4699 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In USP Ziprasidone Related Compound F RS: Change 2-(2-Amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetic acid. C21H23ClN4O2S 430.95 to: Sodium 2-(2-… Read More |
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS | AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS | USP43–NF38 | 8407 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | Change Apparatus 5 (see general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉), a cascade impactor, has been calibrated at 15 L/min specifically to meet the recommendation of the CEN Standard… Read More |
MYCOPHENOLATE MOFETIL TABLETS | PERFORMANCE TESTS/Dissolution <711> | USP43–NF38 | 3049 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In Test 3/Analysis: Change Result = (rU/rS) × CS × D rU = peak response from the Sample solution rS = peak response from the… Read More |
GEMCITABINE FOR INJECTION | IMPURITIES/Organic Impurities | USP43–NF38 | 2094 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In Table 2: Change Cytosinea to: Cytosine AND Delete footnote a AND Update footnote order |
Zinc Acetate | REAGENTS AND REFERENCE TABLES/Reagent Specifications | USP43–NF38 | 6219 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | Change [557-34-6]. to: [5970-45-6]. |
GEMCITABINE HYDROCHLORIDE | IMPURITIES/Organic Impurities | USP43–NF38 | 2093 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In Table 2: Change Cytosinea to: Cytosine AND Delete footnote a AND Update footnote order |
QUAZEPAM | ADDITIONAL REQUIREMENTS/USP Reference standards <11> | USP43–NF38 | 3790 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In USP Quazepam Related Compound A RS: Change 7-Chloro-1-(2,2,2 trifluoroethyl)-5-(2-Fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepine-2-one. to: 7-Chloro-5-(2-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-one. |
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS | AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS | USP43–NF38 | 8407 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | Please see the updated Figure 2 at online.uspnf.com |
CODEINE PHOSPHATE TABLETS | Identification | USP43–NF38 | 1139 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In A.: Change Render the filtrate alkaline with 6 N ammonium hydroxide, extract with several small portions of chloroform, and proceed as directed in Identification test A under Codeine Phosphate Injection, beginning with “… Read More |
GEMCITABINE FOR INJECTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 2094 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In USP Cytosine RS: Change 2(1H)-Pyrimidinone, 4-amino-. to: Cytosine. |
DORZOLAMIDE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 1496 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | In USP Dorzolamide Hydrochloride Related Compound A RS: Change 360.91 to 360.89 |