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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
MUPIROCIN CREAM Related compounds/Table 1 USPNF Online Online 1-May-2022 NA NA In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:… Read More
BROMOCRIPTINE MESYLATE CAPSULES PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-May-2022 NA NA In Analysis: Change
bromocriptine mesylate (C32H40BrN5O5 · CH4SO3)
to:
bromocriptine (C32H40BrN5O5)
AND
In… Read More
DACARBAZINE FOR INJECTION IDENTIFICATION USPNF Online Online 1-May-2022 NA NA Delete
Identification test C
MUPIROCIN CALCIUM IMPURITIES/Organic Impurities/Table 1 USPNF Online Online 1-May-2022 NA NA In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:… Read More
MUPIROCIN NASAL OINTMENT Related compounds/Table 1 USPNF Online Online 1-May-2022 NA NA In footnote 2: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:… Read More
ACYCLOVIR ASSAY/Procedure USPNF Online Online 1-May-2023 NA NA In the Sample solution: Change
0.1 N sodium hydroxide
to:
0.01 N sodium hydroxide
DACARBAZINE FOR INJECTION IMPURITIES USPNF Online Online 1-May-2022 NA NA Delete
Limit of 2-Azahypoxanthine test
MUPIROCIN OINTMENT IMPURITIES/Organic Impurities/Table 2 USPNF Online Online 1-May-2022 NA NA In footnote b: Change
9-{(E)-4-[(2R,3aS,6S,7S,8aRS)-2-{(1RS,2S,3S)-1,3-Dihydroxy-2-methylbutyl}-7-hydroxyhexahydro-2H-furo[3,2-c]pyran-6-yl]-3-methylbut-2-enoyloxy}nonanoic acid.
to:… Read More
MECAMYLAMINE HYDROCHLORIDE USP Reference standards <11> USPNF Online Online 1-May-2022 NA NA In USP Mecamylamine Related Compound A RS: Change
N,1,7,7-Tetramethyl bicyclo [2.2.1]heptan-2-amine.
C11H21N 167.29
to:
N,1,7,7-Tetramethylbicyclo[2.2.1]heptan-2-amine hydrochloride.
C11Read More
MUPIROCIN CALCIUM CHEMICAL INFORMATION USPNF Online Online 1-May-2022 NA NA Change
1075.34
to:
1075.35
<621> CHROMATOGRAPHY ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS USPNF Online Online 1-Dec-2022 NA NA In Liquid Chromatography: Isocratic Elution/Injection volume: Change
Result = (Vinj2 = Vinj1 (L2dc22 )/(L1dc… Read More
POWDERED VALERIAN EXTRACT DEFINITION USPNF Online Online 1-Apr-2022 NA NA Change
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid, on the dried basis.
to:
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid, on the anhydrous basis.
PANTOPRAZOLE SODIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Apr-2022 NA NA In USP Pantoprazole Related Compound E RS: Change
A mixture of the stereoisomers of 6,6′-bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazolyl.
to:
6,6′-Bis(difluoromethoxy)-2,2′-bis[[(3,4-… Read More
CORN STARCH IMPURITIES/Limit of Sulfur Dioxide USPNF Online Online 1-Apr-2022 NA NA In Bromophenol blue indicator solution: Change
0.2 mg/mL of bromophenol blue in dilute alcohol. Filter if necessary.
to:
Dissolve 100 mg of bromophenol blue in 100 mL of dilute alcohol (1 in 5), and filter if necessary.
ONDANSETRON TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Apr-2022 NA NA Change
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
to:
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-… Read More
POWDERED VALERIAN EXTRACT COMPOSITION/Content of Valerenic Acids USPNF Online Online 1-Apr-2022 NA NA In Acceptance criteria: Change
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the dried basis
to:
calculated as the sum of hydroxyvalerenic acid, acetoxyvalerenic acid, and valerenic acid on the… Read More
ONDANSETRON ORAL SOLUTION USP Reference standards <11> USPNF Online Online 1-Apr-2022 NA NA Change
USP Ondansetron Related Compound A RS
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
USP Ondansetron Related Compound C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
Read More
ACYCLOVIR FOR INJECTION IMPURITIES/Procedure USPNF Online Online 1-Apr-2022 NA NA In Standard solution A: Change
0.5 μg/mL of Acyclovir standard solution in Solution A
to:
0.5 μg/mL of USP Acyclovir RS from Acyclovir standard solution in Solution A
AND
In Standard solution… Read More
<621> CHROMATOGRAPHY SYSTEM SUITABILITY USPNF Online Online 1-Dec-2022 NA NA Change
System Repeatability—Assay of an Active Substance or an Excipient
to:
System Repeatability
DIBASIC POTASSIUM PHOSPHATE ASSAY/Procedure USPNF Online Online 1-Apr-2022 NA NA In Analysis: Change
Titrate the Blank with 1 N sodium hydroxide VS, and record the volume of 1 N sodium hydroxide VS consumed. Titrate the excess acid in the Sample solution with 1 N sodium hydroxide VS to the inflection point at pH 4, and… Read More
ONDANSETRON TABLETS IMPURITIES/Organic Impurities USPNF Online Online 1-Apr-2022 NA NA In Table 1/footnotes: Change
b1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.
c1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
d3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one… Read More
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-… Read More
TRAZODONE HYDROCHLORIDE TABLETS IMPURITIES/Organic Impurities USPNF Online Online 1-Mar-2022 NA NA In footnote f of Table 2: Change
1,1-Bis{2-chloro-[4-(3-{1,2,4-triazolo[4,3-a]pyridin-3-(2H)-on-2-yl}propyl)piperazine-1-yl]phenyl}ethane trihydrochloride.
to:
2,2'-{[Ethane-1,1-diylbis(3-chloro-4,1-phenylene)bis(piperazine-4,1-diyl… Read More
BEHENOYL POLYOXYLGLYCERIDES SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> USPNF Online Online 1-Mar-2022 NA NA In Analysis: Change
If the volume of 0.5 N sodium hydroxide VS required for the titration is less than 2 mL,
to:
If the volume of 0.5 N alcoholic potassium hydroxide VS required for the titration is less than 2 mL,
MAGNESIUM OXIDE IMPURITIES/Limit of Calcium USPNF Online Online 1-Dec-2022 NA NA In Analysis: Change
CU = concentration of Magnesium Hydroxide in the Sample solution (mg/mL)
to:
CU = concentration of Magnesium Oxide in the Sample solution (mg/mL)
IODIXANOL IMPURITIES/Limit of 2-Methoxyethanol USPNF Online Online 1-Mar-2022 NA NA In Standard stock solution: Change
0.005 mg/mL of methanol and 0.01 mg each of isopropyl alcohol, secondary butyl alcohol, and 2-methoxyethanol in Internal standard solution
to:
0.005 mg/mL of methanol and 0.01 mg/mL each of… Read More
PROPYLENE GLYCOL DIACETATE IMPURITIES/Organic Impurities USPNF Online Online 1-Mar-2022 NA NA In Analysis: Change
rS = sum of all the peak areas, excluding the solvent peaks from the Standard solution
to:
rS = sum of all the peak areas, excluding the solvent peaks from the Sample… Read More
ZOLEDRONIC ACID IMPURITIES/Organic Impurities USPNF Online Online 1-Mar-2022 NA NA In Analysis: Change
rU = peak response of zoledronic acid from the Sample solution
to:
rU = peak response of any individual impurity from the Sample solution
ONDANSETRON INJECTION USP Reference standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Ondansetron Related Compound A RS: Change
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
to:
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.… Read More
LORATADINE CAPSULES PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-Feb-2022 NA NA In Tier 1/Solution A and Tier 2/Solution B: Change
Tween 20
to:
polysorbate 20
FULVESTRANT CHEMICAL INFORMATION USPNF Online Online 1-Feb-2022 NA NA Change
606.77
to:
606.78
ORPHENADRINE CITRATE EXTENDED-RELEASE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Orphenadrine Related Compound B RS: Change
N-Ethyl-N,N-dimethyl [2-2(methylbenzhydryloxy)ethyl]ammonium chloride;
Also known as N-Ethyl-N,N-dimethyl-2-[phenyl(o-tolyl)methoxy]ethanaminium… Read More
WARFARIN SODIUM TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Warfarin Related Compound A RS: Change
3-(o-Hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one.
to:
3-(2-Hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one.
AND
Change
264.33
to:
264.32
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 ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Ondansetron Related Compound A RS: Change
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
C16H20N2O · HCl 292.80
to:
3-[(Dimethylamino)methyl]-9-… Read More
LEVOFLOXACIN IMPURITIES/Organic Impurities, Procedure 1 USPNF Online Online 1-Feb-2022 NA NA Change
Solution A, Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, Sample solution, and Chromatographic system: Proceed… Read More
FULVESTRANT Related compounds USPNF Online Online 1-Feb-2022 NA NA In footnote 1 of table: Change
Estra-1,3,5(10)-triene-6-one-3,17-diol,7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-(7α,17β)
to:
7α-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-6-one-3,17β-diol
AND
In footnote 2… Read More
ONDANSETRON HYDROCHLORIDE USP Reference standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Ondansetron Related Compound A RS: Change
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
to:
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.… Read More
WARFARIN SODIUM FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Warfarin Related Compound A RS: Change
3-(o-Hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one.
to:
3-(2-Hydroxyphenyl)-5-phenyl-2-cyclohexen-1-one.
AND
Change
264.33
to:
264.32
SORAFENIB TABLETS PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-Feb-2022 NA NA In Tolerances: Change
NLT 75 (Q) of the labeled amount of sorafenib (C21H16ClF3N4O3) is dissolved.
to:
NLT 75% (Q) of the labeled amount of sorafenib (C21H… Read More
ORPHENADRINE CITRATE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2022 NA NA In USP Orphenadrine Related Compound B RS: Change
N-Ethyl-N,N-dimethyl [2-2(methylbenzhydryloxy)ethyl]ammonium chloride; also known as N-ethyl-N,N-dimethyl-2-[phenyl(o-tolyl)methoxy]ethanaminium… Read More
NICARDIPINE HYDROCHLORIDE INJECTION DEFINITION USPNF Online Online 1-Feb-2022 NA NA Change
NTL 90.0%
to:
NLT 90.0%
AMLODIPINE BESYLATE Assay USPNF Online Online 1-Feb-2022 NA NA In Chromatographic system: Change
Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the standard deviation for replicate injections is not more than 2.0%.
to:
Chromatograph the… 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… 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… Read More
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
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:
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