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PDF CSV September 19, 2018 through September 19, 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
<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
ROPIVACAINE HYDROCHLORIDE INJECTION USP Reference standards <11> USP43–NF38 3945 1-Jun-2020 NA NA In USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C8H12ClN 157.64
[CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C8H11N · HCl 157.64
Read More
ROPIVACAINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS USP43–NF38 3943 1-Jun-2020 NA NA In USP Reference Standards <11>/USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C8H12ClN 157.64 [CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C8H… Read More
INDOMETHACIN SUPPOSITORIES ASSAY/Procedure Revision Bulletin (Official December 01, 2019) Online 1-Jun-2020 NA NA In Chromatographic system/Detector: Change
PDA (scan 200–600).
to:
PDA (scan 200–600 nm).
FILGRASTIM ADDITIONAL REQUIREMENTS USP43–NF38 Online 1-Jun-2020 NA NA Change
USP Reference Standards <11>
to:
USP Reference Standards <11>
USP Filgrastim RS
FILGRASTIM IMPURITIES/Organic Impurities USP43–NF38 Online 1-Jun-2020 NA NA In Related Compounds/Standard solution: Change
0.75 mg/mL of in water
to:
0.75 mg/mL of USP Filgrastim RS in water
AND
In Impurities with Charges Different from Filgrastim/Reference solution A: Change
1… Read More
FILGRASTIM ASSAY/Potency USP43–NF38 Online 1-Jun-2020 NA NA In Standard solution: Change
0.5 ng/mL of in Medium B.
to:
0.5 ng/mL of USP Filgrastim RS in Medium B.
AND
In Positive control solution: Change
10 ng/mL of in Medium B
to:
10 ng/mL of USP… Read More
FILGRASTIM IDENTIFICATION/C. Peptide Mapping USP43–NF38 Online 1-Jun-2020 NA NA In Standard solution: Change
Prepare a solution containing 80 µg of and 200 µL of Digestion solution
to:
Prepare a solution containing 80 µg of USP Filgrastim RS and 200 µL of Digestion solution
AND
In System… Read More
DOLASETRON MESYLATE ASSAY/Procedure USP43–NF38 1483 1-Jun-2020 NA NA Change
Mobile phase: Acetonitrile, water, and 1 M ammonium formate (450:440:110), adding 0.19 mL of triethylamine to the acetonitrile portion
to:
Solution A: Add 0.19 mL of triethylamine to each 450 mL of acetonitrile.
Mobile… Read More
ANHYDROUS DIBASIC CALCIUM PHOSPHATE ASSAY/Procedure Harmonization (Official December 01, 2019) Online 1-Jun-2020 NA NA In Analysis: Change
M = actual molarity of the Back-titrant (mM/mL)
to:
M = actual molarity of the Back-titrant (mmol/mL)
AND
Change
F = equivalency factor, 136.06 mg/mM
to:
Read More
POWDERED BILBERRY EXTRACT COMPOSITION USP43–NF38 4813 1-Jun-2020 NA NA In Content of Anthocyanosides and Anthocyanidins/System suitability/Resolution: Change
petunidin-3-O-arabinose
to:
petunidin-3-O-arabinoside
METOPROLOL SUCCINATE USP Reference standards <11> USP43–NF38 2917 1-Jun-2020 NA NA In USP Metoprolol Related Compound C RS: Change
(±)4-[2-Hydroxy-3-(1-methylethyl)aminopropoxy]benzaldehyde.
C13H19NO3 237.29
to:
4-[2-Hydroxy-3-(isopropylamino)propoxy]benzaldehyde hydrochloride.
C… Read More
PRAVASTATIN SODIUM ADDITIONAL REQUIREMENTS USP43–NF38 3645 1-Jun-2020 NA NA In USP Reference Standards <11>/USP Pravastatin Related Compound A RS: Change
446.51
to:
446.52
DOXYCYCLINE CAPSULES PERFORMANCE TESTS USP43–NF38 1519 1-Jun-2020 NA NA In Dissolution <711>: Change
Test 2
to:
Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
DESCRIPTION AND SOLUBILITY REAGENTS AND REFERENCE TABLES/REFERENCE TABLES USP43–NF38 6275 1-Nov-2020 NA NA Change
Incommunicable Acid Hydrochloride:
to:
Aminolevulinic Acid Hydrochloride:
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 Revision Bulletin (Official October 01, 2019) Online 1-May-2020 NA NA In Buffer stage medium: Change
Simulated gastric fluid,
to:
Simulated intestinal fluid,
<1125> NUCLEIC ACID-BASED TECHNIQUES -- GENERAL APPENDICES USP43–NF38 7865 1-May-2020 NA NA In Appendix 2: Delete the Row for
dNTP dinucleotide triphosphate