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PDF CSV March 28, 2022 through March 28, 2024 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
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS/Packaging Definitions Second Supplement to USP43–NF38 Online 1-Dec-2025 NA NA In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-… Read More
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)
<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
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
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.
USP… 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
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-tetrahydro-4H… Read More
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
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.
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 B:… 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.
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 anhydrous… 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.
C11… Read More
DACARBAZINE FOR INJECTION IDENTIFICATION USPNF Online Online 1-May-2022 NA NA Delete
Identification test C
DACARBAZINE FOR INJECTION IMPURITIES USPNF Online Online 1-May-2022 NA NA Delete
Limit of 2-Azahypoxanthine test
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
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
MUPIROCIN CALCIUM CHEMICAL INFORMATION USPNF Online Online 1-May-2022 NA NA Change
1075.34
to:
1075.35
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 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
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
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
<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 (L2 dc22 )/(L1… Read More
CARBAMAZEPINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2022 NA NA In USP Carbamazepine Related Compound A RS: Change
238.28
to:
238.29
AND
In USP Carbamazepine Related Compound B RS: Change
193.24
to:
193.25
AND
In USP 9-Methylacridine RS: Change
193.24
to:
193.25
FLUOCINOLONE ACETONIDE Organic Impurities USPNF Online Online 1-Jun-2022 NA NA In Acceptance criteria/Total impurities: Change
NMT 2.5%. Disregard any peak below 0.05% of the peak area of fluocinolone acetonide from the Standard solution.
to:
NMT 2.5%. Disregard any peak below 0.05% of the peak area of… Read More
DIMENHYDRINATE TABLETS OTHER COMPONENTS/8-Chlorotheophylline USPNF Online Online 1-Jun-2022 NA NA In Analysis: Change
CU = nominal concentration of dimenhydrinate in the Sample solution (mg/mL)
to:
CU = determined concentration of dimenhydrinate in the Sample solution, as obtained in the Assay… Read More
RIFABUTIN CHEMICAL INFORMATION USPNF Online Online 1-Jun-2022 NA NA Change
847.00
to:
847.02
AND
Change
(9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]… Read More
APREPITANT CAPSULES PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-Jun-2022 NA NA Change
Test 1 Dilute 1 mL of phosphoric acid with water to 1 L.
to:
Test 1
AND
Change
Dilute phosphoric acid:
to:
Dilute phosphoric acid: Dilute 1 mL of phosphoric acid with water to 1 L.
<565> BOTANICAL EXTRACTS PREPARATIONS USPNF Online Online 1-Jun-2022 NA NA In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)… Read More
NANDROLONE DECANOATE ASSAY/Procedure USPNF Online Online 1-Jun-2022 NA NA In Analysis: Change
Calculate the percentage of Nandrolone Decanoate (C28H44O3) in the portion of Nandrolone Decanoate taken:
to:
Calculate the percentage of nandrolone decanoate (C28H44O… 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
DOXYCYCLINE HYCLATE CHEMICAL INFORMATION USPNF Online Online 1-Jun-2022 NA NA Change
1025.87
to:
1025.88
DOXYCYCLINE HYCLATE IMPURITIES/Organic Impurities USPNF Online Online 1-Jun-2022 NA NA In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5a… Read More
DOXYCYCLINE HYCLATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
480.13
to:
480.90
IBUPROFEN ORAL SUSPENSION PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-Jun-2022 NA NA In Analysis: Change
Result = (RU/RS) x CS x V x (D/WU) x (1/L) x 100
RU = peak area ratio of ibuprofen to benzophenone from the Read More
ATRACURIUM BESYLATE CHEMICAL INFORMATION USPNF Online Online 1-Jun-2022 NA NA Change
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimeth oxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate, pentamethylene ester
to:
2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate,… Read More
IVERMECTIN CHEMICAL INFORMATION USPNF Online Online 1-Jul-2022 NA NA Change
C48H74O14(Component H2B1a) 875.09
C47H72O14(Component H2B1b) 861.07
Component H2B1a:
Avermectin… Read More
DOXYCYCLINE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… Read More
DOXYCYCLINE FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… Read More
DOXYCYCLINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… Read More
DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… Read More
DOXYCYCLINE HYCLATE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… Read More
DOXYCYCLINE HYCLATE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… Read More
ASCORBIC ACID INJECTION ASSAY/Procedure USPNF Online Online 1-Jul-2022 NA NA In Chromatographic system/Column: Change
150-cm × 6-mm; packing L39
to:
15-cm × 6-mm; packing L39
MILK THISTLE CAPSULES PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution USPNF Online Online 1-Aug-2022 NA NA In Medium: Change
Buffer containing 2% lauryl sulfate; 900 mL
to:
Buffer containing 2% sodium lauryl sulfate; 900 mL
MILK THISTLE TABLETS PERFORMANCE TESTS/Disintegration and Dissolution <2040>, Dissolution USPNF Online Online 1-Aug-2022 NA NA In Medium: Change
Buffer containing 2% lauryl sulfate; 900 mL
to:
Buffer containing 2% sodium lauryl sulfate; 900 mL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS ASSAY/Procedure USPNF Online Online 1-Jul-2022 NA NA In Buffer: Change
Adjust with phosphoric acid to a pH of 6.4 ± 0.01.
to:
Adjust with phosphoric acid to a pH of 6.4 ± 0.1.
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS IMPURITIES/Limit of Homatropine Hydrobromide and Related Substances USPNF Online Online 1-Jul-2022 NA NA In Buffer: Change
Adjust with phosphoric acid to a pH of 6.4 ± 0.01.
to:
Adjust with phosphoric acid to a pH of 6.4 ± 0.1.
AMMONIUM GLYCYRRHIZATE CHEMICAL INFORMATION USPNF Online Online 1-Jul-2022 NA NA Change
840.08
to:
839.97
AMMONIUM GLYCYRRHIZATE ASSAY/Content of Ammonium 18α- and 18β-Glycyrrhizate USPNF Online Online 1-Jul-2022 NA NA In Analysis: Change
MW(Salt) = molecular weight of ammonium glycyrrhizate, 840.08 g/mol
MW(Acid) = molecular weight of glycyrrhizic acid, 821.59 g/mol
to:
MW(Salt) = molecular weight of… Read More