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PDF CSV September 27, 2018 through September 27, 2020 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
METAXALONE TABLETS IMPURITIES Revision Bulletin (Official September 01, 2020) Online 1-Oct-2020 NA NA Change
Organic Impurities
to:
IMPURITIES
Organic Impurities
AMLODIPINE BESYLATE TABLETS IDENTIFICATION/A. USP43–NF38 286 1-Oct-2020 NA NA Change
Spectroscopic Identification Tests 〈197〉, Ultraviolet Spectroscopy: 197U
to:
Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U
AMIODARONE HYDROCHLORIDE IDENTIFICATION/A. USP43–NF38 Online 1-Oct-2020 NA NA This erratum applies to the USP-NF online platform only.
Change
Infrared Absorption 〈197K〉
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
NICOTINE TRANSDERMAL SYSTEM PERFORMANCE TESTS/Drug Release <724> USP43–NF38 3153 1-Oct-2020 NA NA In Tests 1, 2, 4, and 5/Tolerances: Change
conform to Dissolution <711>, Acceptance Table 1.
to:
conform to Acceptance Table 1.
ZONISAMIDE IDENTIFICATION/A. USP43–NF38 4718 1-Oct-2020 NA NA Change
Infrared Absorption 〈197K〉
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
DESVENLAFAXINE FUMARATE IDENTIFICATION/A. USP43–NF38 1281 1-Oct-2020 NA NA Change
Infrared Absorption 〈197〉: [ Note— Methods described in 〈197K〉 or 〈197A〉 may be used.]
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or 197A
VORICONAZOLE IDENTIFICATION/A. USP43–NF38 4643 1-Oct-2020 NA NA Change
Infrared Absorption 〈197K〉
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
TILETAMINE HYDROCHLORIDE IDENTIFICATION/B. USP43–NF38 4382 1-Oct-2020 NA NA Change
Spectroscopic Identification Tests 〈197〉, Ultraviolet Spectroscopy: 197U—
to:
Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U—
TELMISARTAN TABLETS IDENTIFICATION/A. USP43–NF38 4240 1-Oct-2020 NA NA Change
Spectroscopic Identification Tests 〈197〉, Ultraviolet Spectroscopy: 197U:
to:
Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U:
ETIDRONATE DISODIUM IDENTIFICATION/A. USP43–NF38 1782 1-Oct-2020 NA NA Change
Infrared Absorption 〈197〉
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy
DESVENLAFAXINE SUCCINATE IDENTIFICATION/A. USP43–NF38 1283 1-Oct-2020 NA NA Change
Infrared Absorption 〈197〉: [ Note— Methods described in 〈197K〉 or 〈197A〉 may be used.]
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or 197A
DESVENLAFAXINE IDENTIFICATION/A. USP43–NF38 1280 1-Oct-2020 NA NA Change
Infrared Absorption 〈197〉: [ Note—Methods described in 〈197K〉 or 〈197A〉 may be used.]
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or 197A
DALFAMPRIDINE IDENTIFICATION/A. USP43–NF38 1228 1-Oct-2020 NA NA Change
Infrared Absorption 〈197〉: [ Note— Methods described in 〈197K〉 or 〈197A〉 may be used.]
to:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or 197A
DACTINOMYCIN IDENTIFICATION/A. USP43–NF38 1227 1-Oct-2020 NA NA Change
Spectroscopic Identification Tests 〈197〉, Ultraviolet Spectroscopy: 197U
to:
Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U
CLOMIPHENE CITRATE IDENTIFICATION/B. USP43–NF38 1088 1-Oct-2020 NA NA Change
Spectroscopic Identification Tests 〈197〉, Ultraviolet Spectroscopy: 197U
to:
Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U
CEFTIOFUR HYDROCHLORIDE IMPURITIES/High Molecular Weight Impurities USP43–NF38 875 1-Oct-2020 NA NA In Mobile phase: Change
10 g/L of electrophoresis grade sodium dodecyl sulfate in Solution A.
to:
10 g/L of electrophoresis grade sodium dodecyl sulfate in Solution B.
<581> VITAMIN D ASSAY ASSAY/Chromatographic Methods USP43–NF38 6808 1-Sep-2020 NA NA In the second Calculate statement in Procedure 7/Analysis/Precholecalciferol and pre-ergocalciferol response factor: Change
pre-ergolecalciferol
to:
pre-ergocalciferol
CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION Assay USP43–NF38 789 1-Sep-2020 NA NA Change
pH 6.0 buffer, Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Carteolol Hydrochloride.
to:… Read More
THEOPHYLLINE TABLETS Assay USP43–NF38 4328 1-Sep-2020 NA NA Change
Mobile phase, Internal standard solution, and Standard preparation—Prepare as directed in the Assay under Theophylline.
to:
Buffer solution—Transfer 2.72 g of sodium acetate trihydrate to a 2000… Read More
SODIUM IODIDE I 123 CAPSULES Other requirements USP43–NF38 2365 1-Sep-2020 NA NA Change
Other requirements
A solution or suspension prepared by homogenizing 1 or more Capsules in water to yield a concentration of not less than 1 MBq (25 µCi) per mL meets the requirements of the Assay for radioactivity under Sodium… Read More
SODIUM IODIDE I 123 CAPSULES Radiochemical purity USP43–NF38 2365 1-Sep-2020 NA NA Change
Homogenize 1 Capsule in 3 mL of water, add 3 mL of methanol, and centrifuge: the supernatant so obtained meets the requirements of the test for Radiochemical purity under Sodium Iodide I 123 Solution.
to:
Place a measured… Read More
SODIUM IODIDE I 123 CAPSULES Radionuclidic purity USP43–NF38 2365 1-Sep-2020 NA NA Change
A solution or suspension of 1 or more Capsules in water responds to the test for Radionuclidic purity under Sodium Iodide I 123 Solution.
to:
(see Radioactivity <821>)
Using a suitable counting assembly,… Read More
SODIUM IODIDE I 123 CAPSULES Radionuclide identification USP43–NF38 2365 1-Sep-2020 NA NA Change
A solution or suspension of 1 or more Capsules in water responds to the test for Radionuclide identification under Sodium Iodide I 123 Solution.
to:
(see Radioactivity <821>)
The gamma-ray spectrum of a… Read More
CLOMIPRAMINE HYDROCHLORIDE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official July 08, 2020) Online 1-Sep-2020 NA NA In USP Clomipramine Related Compound A RS: Change
458.89
to:
458.90
<208> ANTI-FACTOR XA AND ANTI-FACTOR IIA ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS Anti-Factor Xa and Anti-Factor IIa Assays for Low Molecular Weight Heparins USP43–NF38 6611 1-Aug-2020 NA NA Change
Anti-Factor Xa Activity for Low Molecular Weight Heparin
to:
The following procedure is used where specified in the individual monographs. This assay can be performed manually in plastic tubes utilizing heated block stations or water… Read More
FUROSEMIDE INJECTION Assay USP43–NF38 2054 1-Aug-2020 NA NA Change
Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide.
to:
Mobile phase—Prepare a… Read More
FUROSEMIDE INJECTION Limit of furosemide related compound B USP43–NF38 2054 1-Aug-2020 NA NA Change
Mobile phase, Diluting solution, System suitability solution and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide.
to:
Mobile phase—Prepare a… Read More
FUROSEMIDE TABLETS Assay USP43–NF38 2056 1-Aug-2020 NA NA Change:
Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide.
to:
Mobile phase—Prepare… Read More
FUROSEMIDE TABLETS Limit of furosemide related compound B USP43–NF38 2056 1-Aug-2020 NA NA Change
Mobile phase, Diluting solution, System suitability solution, and Chromatographic system—Prepare as directed in the test for Related compounds under Furosemide.
to:
Mobile phase—Prepare a… Read More
SOTALOL HYDROCHLORIDE TABLETS Identification USP43–NF38 4105 1-Aug-2020 NA NA Change
Weigh and powder a quantity of the Tablets, equivalent to about 250 mg of sotalol hydrochloride, and transfer to a 50-mL volumetric flask. Add 25 mL of methanol, and shake for 10 minutes. Dilute with methanol to volume, mix, and filter: the filtrate so… Read More
METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS ADDITIONAL REQUIREMENTS USP43–NF38 2918 1-Aug-2020 NA NA In Labeling: Change
as metoprolol succinate [(C15H25NO3)2 · C4H6O6].
to:
as metoprolol tartrate [(C15H25NO3)2 · C… Read More
MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official September 01, 2019) Online 1-Aug-2020 NA NA In Test 4/Table 5: Change
45/Tablet and 90 mg/Tablet
to:
45 mg/Tablet and 90 mg/Tablet
METHYLDOPATE HYDROCHLORIDE IDENTIFICATION USP43–NF38 2880 1-Aug-2020 NA NA In C: Change
It responds to Identification test C under Methyldopa.
to:
Sample: 10 mg
Analysis: To the Sample add 0.15 mL of a solution of ninhydrin in sulfuric acid (1 in 250): a dark purple color is produced… Read More
ETHAMBUTOL HYDROCHLORIDE IMPURITIES/Limit of Aminobutanol USP43–NF38 1762 1-Aug-2020 NA NA In Acceptance criteria: Change
The fluorescence intensity of the solution from the Sample solution is NMT 1.0% of the difference between the intensities of the two solutions.
to:
The fluorescence intensity of the solution from the Read More
DIBASIC CALCIUM PHOSPHATE DIHYDRATE IMPURITIES USP43–NF38 708 1-Aug-2020 NA NA In Chloride and Sulfate, Chloride <221>: Change
Sample: 0.2 g of of Dibasic Calcium Phosphate Dihydrate
to:
Sample: 0.2 g of Dibasic Calcium Phosphate Dihydrate
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL APPENDICES/Appendix 1 USP43–NF38 7865 1-Aug-2020 NA NA In footnote 1: Change
http://ts.nist.gov/measurementservices/referencematerials/index.cfm.
to:
https://www.nist.gov/srm.
<111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS COMBINATION OF INDEPENDENT ASSAYS/Method 2 USP43–NF38 6543 1-Aug-2020 NA NA In the second bullet in Alternate weights for inter-assay component of variation: Delete the duplicate equation
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities, Procedure 1/Chromatographic system Revision Bulletin (Official October 01, 2019) Online 1-Jul-2020 NA NA In Detection solution: Change
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate), and heat at 105° for 5 min.
to:
Dissolve 1.25 g of potassium permanganate and 10.0 g of… Read More
PROPYLENE CARBONATE ASSAY/Procedure/Titrimetric system USP43–NF38 5986 1-Jul-2020 NA NA In Mode: Change
Direct titration
to:
Residual titration
NOREPINEPHRINE BITARTRATE CHEMICAL INFORMATION USP43–NF38 3197 1-Jul-2020 NA NA Change
C8H11NO2 · C4H6O6
to:
C8H11NO3 · C4H6O6
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLETS Assay USP43–NF38 1439 1-Jul-2020 NA NA In Procedure: Change
694.83/676.83)(250)CA(rU/rS)
in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,… Read More
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ORAL SOLUTION Assay USP43–NF38 1438 1-Jul-2020 NA NA In Procedure: Change
(694.83/676.83)(25)CA(rU/rS)
in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,… Read More
ATROPINE SULFATE OPHTHALMIC OINTMENT ASSAY/Procedure USP43–NF38 431 1-Jul-2020 NA NA In Analysis: Change
atropine sulfate monohydrate, 694.83
to:
atropine sulfate monohydrate, 694.84
ATROPINE SULFATE INJECTION ASSAY/Procedure USP43–NF38 430 1-Jul-2020 NA NA In Analysis: Change
atropine sulfate monohydrate, 694.85
to:
atropine sulfate monohydrate, 694.84
AND
Change
anhydrous atropine sulfate, 676.83
to:
anhydrous atropine sulfate, 676.82
ATROPINE SULFATE CHEMICAL INFORMATION USP43–NF38 428 1-Jul-2020 NA NA Change
694.83
to:
694.84
ATORVASTATIN CALCIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 414 1-Jul-2020 NA NA In USP Atorvastatin Related Compound B RS: Change
3S,5R Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium… Read More
AMLODIPINE AND ATORVASTATIN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official November 27, 2019) Online 1-Jul-2020 NA NA In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-… Read More
ABIRATERONE ACETATE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 Revision Bulletin (Official November 19, 2019) Online 1-Jul-2020 NA NA In Analysis: Change
rU = peak response of abiratrone acetate from the Sample solution
rS = peak response of abiratrone acetate from the Standard solution
to:
rU =… Read More
TRANYLCYPROMINE SULFATE CHEMICAL INFORMATION USP43–NF38 Online 1-Jun-2020 NA NA See https://www.uspnf.com/errata/tranylcypromine-sulfate-image for correction.
TETRACAINE HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 4295 1-Jun-2020 NA NA In Table 2: Change
Tetracaine hydrochloride related compound B 1.7 0.4
Tetracaine hydrochloride related compound C 2.1 0.4
to:
Tetracaine related compound B 1.7 0.4
Tetracaine related compound C 2.1 0.4