Skip to main content

Errata - English

PDF CSV May 16, 2022 through May 16, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Sort ascending Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS PERFORMANCE TESTS USPNF Online Online 1-Dec-2023 NA NA In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim… Read More
DOXORUBICIN HYDROCHLORIDE INJECTION ASSAY/Procedure USPNF Online Online 1-Nov-2022 NA NA In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
AZTEC MARIGOLD ZEAXANTHIN EXTRACT IDENTIFICATION/C. USPNF Online Online 1-Feb-2023 NA NA Change
(3R,3′S meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 1-Apr-2023 NA NA In Test 2/Analysis: Change
CS = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (ug/mL) in the Standard solution
to:
CS = concentration of USP Norethindrone Acetate… Read More
ATORVASTATIN CALCIUM TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Jul-2023 NA NA In USP Atorvastatin Related Compound B RS: Change
1155.34
to:
1155.36
ECONAZOLE NITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Mar-2022 NA NA In USP Econazole Related Compound B RS: Change
Econazole amine;
2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine.
C15H14Cl3NO 330.64
to:
Econazole amine;
2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)… Read More
AZITHROMYCIN FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2022 NA NA In USP Azithromycin Related Compound F RS: Change
762.97
to:
762.98
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80
POWDERED FORSKOHLII COMPOSITION/Content of Forskolin USPNF Online Online 1-Aug-2022 NA NA In Chromatographic system: Change
Column: 4.6-mm × 25-cm; 5-µm, 100 Å
to:
Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1
DOXORUBICIN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USPNF 2022 Online Online 1-Nov-2022 NA NA In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
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 that… 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
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)
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
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
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
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
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
CARBOMER COPOLYMER CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA See online.uspnf.com for correction
〈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.
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
ESTROPIPATE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-Dec-2021 NA NA Change
436.56
to:
436.57
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
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
AZITHROMYCIN FOR ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Medium: Change
Sodium phosphate buffer, pH of 6.0 (14.2 g/L of disodium hydrogen orthophosphate anhydrous in water, adjusted with dilute hydrochloric acid to a pH of 6.0)
to:
Sodium phosphate buffer, pH 6.0 (14.2 g/L of sodium phosphate,… 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
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
AZITHROMYCIN FOR ORAL SUSPENSION ASSAY/Procedure USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Solution A: Change
orthophosphoric acid
to:
phosphoric acid
<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
<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
CARBOMER INTERPOLYMER CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Please see the updated chemical structure at online.uspnf.com
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.
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
CARBOMER INTERPOLYMER IMPURITIES/Limit of Acrylic Acid USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Analysis: Change
CU = concentration of Carbomer Interpolymer in the Sample solution (g)
to:
CU = concentration of Carbomer Interpolymer in the Sample solution (mg/g)
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
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
FENTANYL CITRATE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
528.59
to:
528.60
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CHEWABLE GELS STRENGTH USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Vitamins B3 (as Niacinamide), B6, and Folic Acid, Method 1/System suitability: Change
[Note—The relative retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 1.6, 2.0, and 3.0 respectively.]
to:
[Note—The relative… 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)
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
FENTANYL CITRATE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In both variable definition lists in Analysis: Change
Mr1 = molecular weight of fentanyl citrate, 528.59
Mr2 = molecular weight of fentanyl, 336.47
to:
Mr1 = molecular… Read More
MALTITOL SOLUTION IMPURITIES/Limit of Nickel USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
Solution A: [Note—Prepare this solution fresh weekly.]
to:
Standard nickel solution A: [Note—Prepare this solution fresh weekly.]
<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
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
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
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
CLOZAPINE IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In System suitability/Suitability requirements/Resolution: Change
NLT 2.5 between demethyl clozapine and clozapine
to:
NLT 2.5 between demethyl clozapine and clozapine, System suitability solution
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
PACLITAXEL INJECTION TITLE USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
Paclit 1axel Injection
to:
Paclitaxel Injection
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.]
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