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PDF CSV October 17, 2023 through October 18, 2025 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
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.
C13Read 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:
RALTEGRAVIR CHEWABLE TABLETS ASSAY/Procedure USP43–NF38 3835 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
ALOSETRON HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 141 1-May-2020 NA NA In System suitability/Suitability requirements/Resolution: Change
NLT 7
to:
NLT 3
CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 915 1-May-2020 NA NA In USP Cetirizine Related Compound A RS: Change
506.98
to:
506.97
BUDESONIDE IMPURITIES/Organic Impurities USP43–NF38 604 1-May-2020 NA NA In footnote k in Table 2: Change
16α,17-[Butylidenebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione-21-acetate.
to:
16α,17-[Butylidenebis(oxy)]-11β-hydroxypregna-1,4-diene-3,20-dione-21-yl acetate.
CARISOPRODOL IMPURITIES/Organic Impurities USP43–NF38 776 1-May-2020 NA NA In Table 2: Change
Carisoprdol related compound Aa
to:
Carisoprodol related compound Aa
REPOSITORY CORTICOTROPIN INJECTION ADDITIONAL REQUIREMENTS USP43–NF38 1174 1-May-2020 NA NA In USP Reference Standards <11>: Add
USP Ascorbic Acid RS
DAPSONE TABLETS IDENTIFICATION/B. USP43–NF38 1241 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
DEMECLOCYCLINE HYDROCHLORIDE SPECIFIC TESTS/Loss on Drying USP43–NF38 1248 1-May-2020 NA NA In Analysis: Change
Dry the Sample at 60° for 3 h.
to:
Dry the Sample in a capillary-stoppered bottle in vacuum at 60° for 3 h.
DEXAMETHASONE ACETATE Chromatographic purity USP43–NF38 1290 1-May-2020 NA NA Change
Format buffer
to:
Formate buffer
DIHYDROERGOTAMINE MESYLATE Assay USP43–NF38 1388 1-May-2020 NA NA Change
Diluent 1—Prepare a solution of 0.1 mL of phosphoric acid in 1000 mL of water.
Diluent 2—Prepare a mixture of Diluent 1 and acetonitrile (60:40).
to:
Diluent 1—Prepare a solution of 0.1 mL of phosphoric acid in 1000 mL… Read More
EPINEPHRINE IMPURITIES/Organic Impurities USP43–NF38 1645 1-May-2020 NA NA In the third calculation in the Analysis: Change
CU = concentration of Epinephrine in the Sample solution (mg/mL)
to:
CU = concentration of Epinephrine in the Sample solution (µg/mL)
EPINEPHRINE IMPURITIES/Enantiomeric Purity USP43–NF38 Online 1-May-2020 NA NA This erratum applies to the USP-NF ONLINE platform only.
In System suitability solution: Change
0.03 mg/mL of in Mobile phase
to:
0.03 mg/mL of USP Racepinephrine Hydrochloride RS in Mobile phase
EPINEPHRINE ADDITIONAL REQUIREMENTS USP43–NF38 Online 1-May-2020 NA NA This erratum applies to the USP-NF ONLINE platform only.
In USP Reference Standards <11>: Add
USP Racepinephrine Hydrochloride RS
LEUCOVORIN CALCIUM FOR INJECTION ASSAY/Procedure/Chromatographic system USP43–NF38 2569 1-May-2020 NA NA Delete
Run time: 2 times the retention time of the leucovorin peak
LEVONORDEFRIN Identification/B: USP43–NF38 2611 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>—
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
LOPERAMIDE HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 2658 1-May-2020 NA NA In System suitability/Suitability requirements/Peak-to-valley ratio: Change
NLT 1.5 for loperamide related compounds G and H; NLT 1.5 for loperamide related compounds E and A, System suitability solution
to:
NLT 1.5 for… Read More
MENADIONE ASSAY/Procedure USP43–NF38 2780 1-May-2020 NA NA In Endpoint detection: Change
Potentiometric
to:
Visual
MEXILETINE HYDROCHLORIDE CHEMICAL INFORMATION USP43–NF38 2943 1-May-2020 NA NA Change
[5370-01-04].
to:
[5370-01-4].
NIACIN IDENTIFICATION/B. USP43–NF38 3138 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
PANTOPRAZOLE SODIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 3388 1-May-2020 NA NA In USP Pantoprazole Related Compound E RS: Change
C34H28F4N6O8S2 764.74
to:
C32H28F4N6O8S2 764.72
POLYVINYL ALCOHOL IDENTIFICATION/A. USP43–NF38 3593 1-May-2020 NA NA Change
Infrared Absorption <197K>
to:
Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K
PROPOFOL IMPURITIES/Organic Impurities, Procedure 2 USP43–NF38 3739 1-May-2020 NA NA In Table 3: Delete
Propofol related compound Bb 0.8 1.0 0.05
AND
Change
Propofol related compound Ac
to:
Propofol related compound Ab
AND
Change
b2,6-Diisopropylbenzoquinone.
Read More
PROPRANOLOL HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 3746 1-May-2020 NA NA In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 5.0,
to:
NMT 5.0%,
RALTEGRAVIR TABLETS DEFINITION USP43–NF38 3834 1-May-2020 NA NA Change
(C20H20FN6O5)
to:
(C20H21FN6O5)
RALTEGRAVIR TABLETS ASSAY/Procedure USP43–NF38 3834 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
RALTEGRAVIR TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3834 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
RALTEGRAVIR CHEWABLE TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3835 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
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
<856> NEAR-INFRARED SPECTROSCOPY 4. VALIDATION AND VERIFICATION USP43–NF38 7161 1-May-2020 NA NA In 4.1 Validation/4.1.1 Accuracy/Validation criteria/Criteria 1: Change
Suitable agreement between SEP
to:
Suitable agreement between the standard error of prediction (SEP)
<191> IDENTIFICATION TESTS—GENERAL CHEMICAL IDENTIFICATION TESTS USP43–NF38 6587 1-Aug-2020 NA NA In Bicarbonate/B.: Change
(1:20)
to:
(1 in 20)
AND
In Borate/A.: Change
(1:50):
to:
(1 in 50):
AND
In Calcium/A.: Change
(1:20)
to:
(1 in 20)
AND
In Carbonate/B.:… Read More
0.02 M EDETATE DISODIUM VS REAGENTS AND REFERENCE TABLES/Solutions USP43–NF38 6240 1-May-2020 NA NA Change
0.7444 g
to:
7.444 g
0.002 M EDETATE DISODIUM VS REAGENTS AND REFERENCE TABLES/Solutions USP43–NF38 6240 1-May-2020 NA NA Change
0.0744 g
to:
0.744 g
SUCROSE PALMITATE IMPURITIES/Inorganic Impurities USP43–NF38 6078 1-May-2020 NA NA In Fats and Fixed Oils, Acid Value <401>: Change
NMT 6.0%,
to:
NMT 6.0,
SODIUM METABISULFITE IMPURITIES/Limit of Chloride USP43–NF38 6020 1-May-2020 NA NA In Analysis: Change
(see Nephelometry, Turbidimetry, and Visual Comparison <855>).
to:
(see Visual Comparison <630>).
POLYOXYL 35 CASTOR OIL IDENTIFICATION/C. Identity by Fatty Acid Composition USP43–NF38 5956 1-May-2020 NA NA In System suitability/Suitability requirements/Relative standard deviation: Change
linoeate
to:
linoleate
HEXYLENE GLYCOL IMPURITIES/Organic Impurities USP43–NF38 5814 1-May-2020 NA NA In Any other individual impurity/Relative Response Factor in Table 2: Change

to:
1.0
GLYCERYL MONO AND DICAPRYLATE IDENTIFICATION/A. Fatty Acid Composition USP43–NF38 5794 1-May-2020 NA NA In Standard solution 3: Change
USP Methyl Caproate RS, USP Methyl Caprylate RS, USP Methyl Caprate RS, USP Methyl Laurate RS, and USP Methyl Laurate RS.
to:
USP Methyl Caproate RS, USP Methyl Caprylate RS, USP Methyl Caprate RS, USP Methyl Laurate RS… Read More
CAPRYLIC ACID ASSAY/Procedure/Chromatographic system USP43–NF38 5664 1-May-2020 NA NA In Column: Change
30-cm
to:
30-m
RALTEGRAVIR CHEWABLE TABLETS IMPURITIES/Organic Impurities USP43–NF38 3835 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
VITAMIN E ASSAY/Alpha Tocopheryl Acid Succinate USP43–NF38 4637 1-May-2020 NA NA In Sample solution: Change
tocoopheryl
to:
tocopheryl
VITAMIN A TABLETS ASSAY/Procedure 2 USP43–NF38 4635 1-May-2020 NA NA In the variable definition list in Analysis: Change
Sample solution 1
to:
Sample solution
SACCHARIN SODIUM SPECIFIC TESTS/Readily Carbonizable Substances Test <271> USP43–NF38 3965 1-May-2020 NA NA In Matching fluid A: Change
ferric chloride TS,
to:
ferric chloride CS,
WATER-SOLUBLE VITAMINS TABLETS STRENGTH USP43–NF38 5512 1-May-2020 NA NA In Biotin, Method 3/Solid-phase extraction: Change
anion-xchange
to:
anion-exchange
AND
In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
,… Read More
RALTEGRAVIR TABLETS IMPURITIES/Organic Impurities USP43–NF38 3834 1-May-2020 NA NA In Analysis: Change
Mr1 = molecular weight of raltegravir, 444.44
to:
Mr1 = molecular weight of raltegravir, 444.42
WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP43–NF38 5552 1-May-2020 NA NA In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
, calcium pantothenate (C18H32CaN2O10), and folic acid (C19… Read More