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PDF CSV July 2, 2018 through July 2, 2020 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
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities, Procedure 1/Chromatographic system Revision Bulletin (Official October 01, 2019) Online 1-Jul-2020 NA NA In Detection solution: Change
Dissolve 1.25 g of potassium permanganate and 10.0 g of sodium hydroxide in 500 mL of water (prepared fresh for each plate), and heat at 105° for 5 min.
to:
Dissolve 1.25 g of potassium permanganate and 10.0 g of… Read More
PROPYLENE CARBONATE ASSAY/Procedure/Titrimetric system USP43–NF38 5986 1-Jul-2020 NA NA In Mode: Change
Direct titration
to:
Residual titration
NOREPINEPHRINE BITARTRATE CHEMICAL INFORMATION USP43–NF38 3197 1-Jul-2020 NA NA Change
C8H11NO2 · C4H6O6
to:
C8H11NO3 · C4H6O6
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLETS Assay USP43–NF38 1439 1-Jul-2020 NA NA In Procedure: Change
694.83/676.83)(250)CA(rU/rS)
in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,… Read More
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ORAL SOLUTION Assay USP43–NF38 1438 1-Jul-2020 NA NA In Procedure: Change
(694.83/676.83)(25)CA(rU/rS)
in which 694.83 and 676.83 are the molecular weights of atropine sulfate monohydrate and anhydrous atropine sulfate,… Read More
ATROPINE SULFATE OPHTHALMIC OINTMENT ASSAY/Procedure USP43–NF38 431 1-Jul-2020 NA NA In Analysis: Change
atropine sulfate monohydrate, 694.83
to:
atropine sulfate monohydrate, 694.84
ATROPINE SULFATE INJECTION ASSAY/Procedure USP43–NF38 430 1-Jul-2020 NA NA In Analysis: Change
atropine sulfate monohydrate, 694.85
to:
atropine sulfate monohydrate, 694.84
AND
Change
anhydrous atropine sulfate, 676.83
to:
anhydrous atropine sulfate, 676.82
ATROPINE SULFATE CHEMICAL INFORMATION USP43–NF38 428 1-Jul-2020 NA NA Change
694.83
to:
694.84
ATORVASTATIN CALCIUM ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP43–NF38 414 1-Jul-2020 NA NA In USP Atorvastatin Related Compound B RS: Change
3S,5R Isomer, or (3S,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium… Read More
AMLODIPINE AND ATORVASTATIN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official November 27, 2019) Online 1-Jul-2020 NA NA In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-… Read More
ABIRATERONE ACETATE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 Revision Bulletin (Official November 19, 2019) Online 1-Jul-2020 NA NA In Analysis: Change
rU = peak response of abiratrone acetate from the Sample solution
rS = peak response of abiratrone acetate from the Standard solution
to:
rU =… Read More
TRANYLCYPROMINE SULFATE CHEMICAL INFORMATION USP43–NF38 Online 1-Jun-2020 NA NA See https://www.uspnf.com/errata/tranylcypromine-sulfate-image for correction.
TETRACAINE HYDROCHLORIDE IMPURITIES/Organic Impurities USP43–NF38 4295 1-Jun-2020 NA NA In Table 2: Change
Tetracaine hydrochloride related compound B 1.7 0.4
Tetracaine hydrochloride related compound C 2.1 0.4
to:
Tetracaine related compound B 1.7 0.4
Tetracaine related compound C 2.1 0.4
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
Read More
ROPIVACAINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS USP43–NF38 3943 1-Jun-2020 NA NA In USP Reference Standards <11>/USP Ropivacaine Related Compound A RS: Change
2,6-Dimethylaniline hydrochloride.
C8H12ClN 157.64 [CAS-21436-98-6].
to:
2,6-Dimethylaniline hydrochloride.
C8H… 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).
FILGRASTIM ADDITIONAL REQUIREMENTS USP43–NF38 Online 1-Jun-2020 NA NA Change
USP Reference Standards <11>
to:
USP Reference Standards <11>
USP Filgrastim RS
FILGRASTIM IMPURITIES/Organic Impurities USP43–NF38 Online 1-Jun-2020 NA NA In Related Compounds/Standard solution: Change
0.75 mg/mL of in water
to:
0.75 mg/mL of USP Filgrastim RS in water
AND
In Impurities with Charges Different from Filgrastim/Reference solution A: Change
1… Read More
FILGRASTIM ASSAY/Potency USP43–NF38 Online 1-Jun-2020 NA NA In Standard solution: Change
0.5 ng/mL of in Medium B.
to:
0.5 ng/mL of USP Filgrastim RS in Medium B.
AND
In Positive control solution: Change
10 ng/mL of in Medium B
to:
10 ng/mL of USP… Read More
FILGRASTIM IDENTIFICATION/C. Peptide Mapping USP43–NF38 Online 1-Jun-2020 NA NA In Standard solution: Change
Prepare a solution containing 80 µg of and 200 µL of Digestion solution
to:
Prepare a solution containing 80 µg of USP Filgrastim RS and 200 µL of Digestion solution
AND
In System… Read More
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… Read More
ANHYDROUS DIBASIC CALCIUM PHOSPHATE ASSAY/Procedure Harmonization (Official December 01, 2019) Online 1-Jun-2020 NA NA In Analysis: Change
M = actual molarity of the Back-titrant (mM/mL)
to:
M = actual molarity of the Back-titrant (mmol/mL)
AND
Change
F = equivalency factor, 136.06 mg/mM
to:
Read More
POWDERED BILBERRY EXTRACT COMPOSITION USP43–NF38 4813 1-Jun-2020 NA NA In Content of Anthocyanosides and Anthocyanidins/System suitability/Resolution: Change
petunidin-3-O-arabinose
to:
petunidin-3-O-arabinoside
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.
C… Read 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:
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… 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… Read More
CAPRYLIC ACID ASSAY/Procedure/Chromatographic system USP43–NF38 5664 1-May-2020 NA NA In Column: Change
30-cm
to:
30-m
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
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:… Read More
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
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… Read More
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
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
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%
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,
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