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PDF CSV October 21, 2019 through October 21, 2021 See all Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
PYRANTEL PAMOATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 2 Online 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
SACCHARIN SPECIFIC TESTS/Readily Carbonizable Substances Test <271> USPNF 2021 ISSUE 1 Online 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 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 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 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 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,… Read More
HYDROXYETHYL CELLULOSE IMPURITIES/Aldehydes USPNF 2021 ISSUE 1 Online 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 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 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… Read More
RIFABUTIN IMPURITIES/Organic Impurities, Procedure 2 USPNF 2021 ISSUE 1 Online 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 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〉, Read More
QUETIAPINE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities/System Suitability USPNF 2021 ISSUE 1 Online 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 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 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:
(… Read More
〈1051〉 CLEANING GLASS APPARATUS CLEANING VALIDATION BEST PRACTICES USPNF 2021 ISSUE 1 Online 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 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 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 1-Sep-2021 NA NA Delete
Sample: 1 g
<197> SPECTROSCOPIC IDENTIFICATION TESTS NEAR-INFRARED AND RAMAN SPECTROSCOPY USPNF 2021 ISSUE 1 Online 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… Read More
QUETIAPINE EXTENDED-RELEASE TABLETS ASSAY/Procedure/System Suitability USPNF 2021 ISSUE 1 Online 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 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 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… Read More
LUMEFANTRINE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 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
CODEINE PHOSPHATE TABLETS Limit of morphine USP43–NF38 1139 1-Aug-2021 NA NA Change
A 1-mL portion of the filtrate from Identification test B meets the requirements of the test for Limit of morphine under Codeine Phosphate.
to:
Dissolve about 50 mg of potassium ferricyanide in 10 mL of water… Read More
ZIPRASIDONE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 4699 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… Read More
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS USP43–NF38 8407 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… Read More
MYCOPHENOLATE MOFETIL TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3049 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… Read More
GEMCITABINE FOR INJECTION IMPURITIES/Organic Impurities USP43–NF38 2094 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 1-Aug-2021 NA NA Change
[557-34-6].
to:
[5970-45-6].
GEMCITABINE HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 2093 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 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 1-Aug-2021 NA NA Please see the updated Figure 2 at online.uspnf.com
CODEINE PHOSPHATE TABLETS Identification USP43–NF38 1139 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 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 1-Aug-2021 NA NA In USP Dorzolamide Hydrochloride Related Compound A RS: Change
360.91
to
360.89
ONDANSETRON INJECTION Assay USP43–NF38 3265 1-Aug-2021 NA NA In Chromatographic system: Change
The liquid chromatograph is equipped with a 216-nm detector and a 4.6-mm × 20-cm column that contains packing L10.
to:
The liquid chromatograph is equipped with a 216-nm detector and a 4.6-mm × 25-cm column… Read More
GEMCITABINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 2093 1-Aug-2021 NA NA In USP Cytosine RS: Change
2(1H)-Pyrimidinone, 4-amino-.
to:
Cytosine.
QUAZEPAM TABLETS ADDITIONAL REQUIREMENTS/USP Reference standards <11> USP43–NF38 3791 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.
CLOZAPINE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Jul-2021 NA NA In Table 2: Change
Demethyl clozapin
to:
Demethyl clozapine
DACTINOMYCIN CHEMICAL INFORMATION USP43–NF38 Online 1-Jul-2021 NA NA Please see the updated chemical structure at online.uspnf.com
AMIODARONE HYDROCHLORIDE INJECTION IMPURITIES/Limit of Iodide USP43–NF38 254 1-Jul-2021 NA NA In Potassium iodate solution: Change
10.7 g/L of potassium iodide in water
to:
10.7 g/L of potassium iodate in water
AMITRIPTYLINE HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 263 1-Jul-2021 NA NA In USP Amitriptyline Related Compound B RS: Change
295.42
to:
295.43
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS ADDITIONAL REQUIREMENTS/USP References Standards <11> Revision Bulletin (Official May 01, 2021) Online 1-Jul-2021 NA NA In USP Benazepril Related Compound B RS: Change
(3S) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS… Read More
KETOROLAC TROMETHAMINE IMPURITIES/Organic Impurities USP43–NF38 2513 1-Jul-2021 NA NA Change
Mobile phase, Diluent, System suitability solution, Standard solution, and Sample solution: Proceed as directed in the Assay.
to:
Mobile phase, Diluent, System suitability solution, Standard solution, Sample… Read More
BENAZEPRIL HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP References standards <11> USP43–NF38 488 1-Jul-2021 NA NA In USP Benazepril Related Compound A RS: Change
(3R) 3-[[(1R) 1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride.
to:
2-[(R)-3-{[(R)-1-Ethoxy-1… Read More
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official March 01, 2021) Online 1-Jul-2021 NA NA In Test 14/Analysis: Delete
Result4 = {(C4 × V) + [(C3 + C2 + C1) × VS]} × (1/L) × 100
LANSOPRAZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 2551 1-Jul-2021 NA NA In USP Lansoprazole Related Compound B RS: Change
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-pyridin-2-yl] methyl]sulfanyl]-1H-benzimidazole.
C16H14F3N3OS 353.36
to:
2-{[(3-Methyl-4-(2,2,2-… Read More
GLYBURIDE CHEMICAL INFORMATION USP43–NF38 2125 1-Jul-2021 NA NA Change
1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohex-ylurea
to:
1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea
NORTRIPTYLINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-Jul-2021 NA NA In USP Amitriptyline Related Compound B RS: Change
295.42
to:
295.43
BENAZEPRIL HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP References Standards <11> USP43–NF38 Online 1-Jul-2021 NA NA In USP Benazepril Related Compound B RS: Change
(3S)-3-[[(1R)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride;
Also known as 2-[(SR)-3-{[(RS)-1-… Read More