Skip to main content

Errata - English

PDF CSV March 29, 2022 through March 29, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
AMLODIPINE BESYLATE Related compounds/Test 2 USPNF Online Online 1-Feb-2022 NA NA In Chromatographic system: Change
Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 10.0%.
to:
Chromatograph the Read More
ONDANSETRON USP Reference standards <11> USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA Change
USP Ondansetron RS
USP Ondansetron Related Compound C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
USP Ondansetron Related Compound D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
to:
USP… Read More
CARBOPLATIN FOR INJECTION IMPURITIES/Limit of 1,1-Cyclobutanedicarboxylic Acid USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In Chromatographic system/Column: Change
4.0-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
CALCIUM SACCHARATE ASSAY/Procedure USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In Analysis: Change
Result = {[(VSVB) × N × F]/W} × 100
to:
Result = {[(VSVB) × M × F]/W} × 100
AND
Change
Read More
EXTENDED PHENYTOIN SODIUM CAPSULES ASSAY/Procedure Revision Bulletin (Official March 01, 2021) Online 1-Jan-2022 NA NA In Sample solution: Change
Nominally 0.6 mg/mL of phenytoin
to:
Nominally 0.6 mg/mL of phenytoin sodium
AND
In Analysis: Change
CU = nominal concentration of phenytoin in the Sample solution (mg/mL)
to… Read More
CARBOPLATIN IMPURITIES/Limit of 1,1-Cyclobutanedicarboxylic Acid USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In Chromatographic system/Column: Change
4.0-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
SUCCINYLCHOLINE CHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In USP Succinylmonocholine Chloride RS: Change
Ethanaminium, 2-(carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride.
to:
Ethanaminium, 2-(3-carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride;
Also… Read More
ATORVASTATIN CALCIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In USP Atorvastatin Related Compound C RS: Change
C66H66F4N4O10
to:
C66H66CaF4N4O10
AND
In USP Atorvastatin Related Compound E RS: Change… Read More
EXTENDED PHENYTOIN SODIUM CAPSULES IMPURITIES/Organic Impurities Revision Bulletin (Official March 01, 2021) Online 1-Jan-2022 NA NA In both Calculations in Analysis: Change
CU = nominal concentration of phenytoin in the Sample solution (µg/mL)
to:
CU = nominal concentration of phenytoin sodium in the Sample solution (µg/mL)
PRAZOSIN HYDROCHLORIDE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In Sensitivity solution: Change
0.05 µg/mL of USP Prazosin Hydrochloride RS in Mobile phase from the Standard solution
to:
0.5 µg/mL of USP Prazosin Hydrochloride RS in Mobile phase from the Standard solution
CAPTOPRIL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-Dec-2021 NA NA In USP Captopril Disulfide RS: Change
L-Proline, 1,1ʹ-[dithiobis(2-methyl-1-oxo-3,1-propanediyl)]bis-[S-(R*,R*)]-.
to:
(2ʹS)-[(2S,2ʹS)-3,3ʹ-Disulfanediylbis(2-methylpropanoyl)]di-L-proline.
ELEUTHERO ROOT AND RHIZOME DRY EXTRACT ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 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 FOR INJECTION IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Dec-2021 NA NA Delete
Diluent: 4.0 mg/mL of citric acid in water
ELEUTHERO ROOT AND RHIZOME ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 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
ESTROPIPATE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-Dec-2021 NA NA Change
436.56
to:
436.57
ISOSORBIDE DINITRATE EXTENDED-RELEASE TABLETS Dissolution <711> USPNF 2021 ISSUE 1 Online 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, since… 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
This… Read More
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
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〉, Nuclear… 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:
(see 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 and Practice… Read More