Skip to main content

Errata - English

PDF CSV February 16, 2023 through February 18, 2025 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
ROPIVACAINE HYDROCHLORIDE INJECTION USP Reference standards <11> USP43–NF38 3945 1-Jun-2020 NA NA In USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C8H12ClN 157.64
[CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C8H11N · HCl 157.64
AND
In USP… Read More
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.
DOLASETRON MESYLATE ASSAY/Procedure USP43–NF38 1483 1-Jun-2020 NA NA Change
Mobile phase: Acetonitrile, water, and 1 M ammonium formate (450:440:110), adding 0.19 mL of triethylamine to the acetonitrile portion
to:
Solution A: Add 0.19 mL of triethylamine to each 450 mL of acetonitrile.
Mobile phase… Read More
INDOMETHACIN SUPPOSITORIES ASSAY/Procedure Revision Bulletin (Official December 01, 2019) Online 1-Jun-2020 NA NA In Chromatographic system/Detector: Change
PDA (scan 200–600).
to:
PDA (scan 200–600 nm).
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
OIL- AND WATER-SOLUBLE VITAMINS TABLETS STRENGTH USP43–NF38 5419 1-May-2020 NA NA In the variable definition for F in Vitamin E, Method 2/Analysis: Change
1/2 for products labeled to contain all-rac vitamin E sources)
to:
1/2 (for products labeled to contain all-rac vitamin E sources)
AND
In Biotin,… Read More
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
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
LEVONORDEFRIN Identification/B: USP43–NF38 2611 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>—
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
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
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
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,
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 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
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
OIL-SOLUBLE VITAMINS TABLETS STRENGTH USP43–NF38 5356 1-May-2020 NA NA In Vitamin E, Method 3/Analysis: Change
alpha -ocopheryl acetate
to:
alpha-tocopheryl acetate
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.
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
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
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>).
MEXILETINE HYDROCHLORIDE CHEMICAL INFORMATION USP43–NF38 2943 1-May-2020 NA NA Change
[5370-01-04].
to:
[5370-01-4].
<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)
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 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
VITAMIN E ASSAY/Alpha Tocopheryl Acid Succinate USP43–NF38 4637 1-May-2020 NA NA In Sample solution: Change
tocoopheryl
to:
tocopheryl
REPOSITORY CORTICOTROPIN INJECTION ADDITIONAL REQUIREMENTS USP43–NF38 1174 1-May-2020 NA NA In USP Reference Standards <11>: Add
USP Ascorbic Acid RS
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP43–NF38 5476 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
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)
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
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
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
POLYVINYL ALCOHOL IDENTIFICATION/A. USP43–NF38 3593 1-May-2020 NA NA Change
Infrared Absorption <197K>
to:
Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K
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
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,
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.
OIL-SOLUBLE VITAMINS TABLETS ADDITIONAL REQUIREMENTS/Labeling USP43–NF38 5356 1-May-2020 NA NA In footnote 1: Change
-alpha-tocopheryl
to:
all-rac-alpha-tocopheryl
AND
Change
USP Vitamin E unit
to:
USP Vitamin E Unit
AND
Change
2R-alphatocopherol
to:
2R-alpha-tocopherol
DEXAMETHASONE ACETATE Chromatographic purity USP43–NF38 1290 1-May-2020 NA NA Change
Format buffer
to:
Formate buffer
CAPRYLIC ACID ASSAY/Procedure/Chromatographic system USP43–NF38 5664 1-May-2020 NA NA In Column: Change
30-cm
to:
30-m
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
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,
NIACIN IDENTIFICATION/B. USP43–NF38 3138 1-May-2020 NA NA Change
Ultraviolet Absorption <197U>
to:
Spectroscopic Identification Tests <197>, Ultraviolet-Visible Spectroscopy: 197U
<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
RALTEGRAVIR TABLETS DEFINITION USP43–NF38 3834 1-May-2020 NA NA Change
(C20H20FN6O5)
to:
(C20H21FN6O5)
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
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
CALCIUM AND VITAMIN D WITH MINERALS TABLETS STRENGTH USP43–NF38 4845 1-May-2020 NA NA In Calcium, Copper, Magnesium, Manganese, and Zinc, Method 2/Acceptance criteria: Change
NLT 90.0%–125.0%
to:
90.0%–125.0%
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
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
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
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