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Errata - English

PDF CSV November 24, 2022 through November 24, 2024 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
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
ANTITHROMBIN III HUMAN ADDITIONAL REQUIREMENTS USP42–NF37 350 1-Apr-2020 NA NA In Labeling: Change
USP Antithrombin III Units.
to:
Antithrombin III IU.
ITRACONAZOLE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 1 Revision Bulletin (Official August 01, 2019) Online 1-Apr-2020 NA NA In System suitability/Suitability requirements/Relative standard deviation: Change
NMT 2.0% for 5 replicate injections
to:
NMT 2.0% for 5 replicates
ANTITHROMBIN III HUMAN SPECIFIC TESTS USP42–NF37 350 1-Apr-2020 NA NA In Pyrogen Test <151>: Change
USP Antithrombin III Units
to:
Antithrombin III IU
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 1 USP42–NF37 2598 1-Mar-2020 NA NA In Analysis: Change
V = volume of Medium, 900 mL
to:
V = volume of Medium, 800 mL
DICLOXACILLIN SODIUM CAPSULES PERFORMANCE TESTS USP42–NF37 1330 1-Mar-2020 NA NA In Dissolution <711>: Change
Sample solution: Sample per the chapter. Dilute with Medium to a concentration that is similar to the Standard solution.
Tolerances: NLT 75% (Q) of the labeled amount of… Read More
CALCIUM ACETATE CAPSULES PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official January 01, 2020) Online 1-Mar-2020 NA NA In Test 1/Analysis: Change
dissolved at time point (i):
Resulti = (rU/rS) × CS × V × D × (1/L) × 100
to:
dissolved:
Read More
FLUNIXIN MEGLUMINE INJECTION IMPURITIES/Organic Impurities USP42–NF37 1890 1-Mar-2020 NA NA In Sensitivity solution: Change
in Diluent from the Standard solution
to:
in Diluent
POLYETHYLENE GLYCOL CHEMICAL INFORMATION USP42–NF37 5882 1-Feb-2020 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/january-2020-errata-with-image.pdf for correction
ALFADEX CHEMICAL INFORMATION USP42–NF37 5561 1-Feb-2020 NA NA Change
972.84
to:
972.85
MEROPENEM FOR INJECTION ASSAY/Procedure Second Supplement to USP42–NF37 9216 1-Feb-2020 NA NA In Mobile phase: Change
Solution A
to:
Buffer
<857> ULTRAVIOLET-VISIBLE SPECTROSCOPY QUALIFICATION OF UV-VIS SPECTROMETERS Second Supplement to USP42–NF37 9570 1-Jan-2020 NA NA In all instances in Table 4: Change
<
to:

AND
In Control of Photometric Response/Acidic Nicotinic Acid Solutions in 0.1 N Hydrochloric Acid/paragraph 1: Change
Using nicotinic acid solutions, the absorbance accuracy… Read More
CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION IMPURITIES/Organic Impurities USP42–NF37 1195 1-Jan-2020 NA NA In Standard solution: Change
in Solution B
to:
in Diluent
<121> INSULIN ASSAYS ASSAY/Rabbit Blood Sugar Method—Quantitative Revision Bulletin (Official May 01, 2019) Online 1-Jan-2020 NA NA In Standard stock solution: Change
of USP Insulin RS of the appropriate species
to:
of the USP Insulin Reference Standard of the appropriate species
AND
In Sample stock solution: Change
of USP Insulin RS of the appropriate species.… Read More
CUPRIC CHLORIDE REAGENTS AND REFERENCE TABLES/Reagent Specifications USP42–NF37 6092 1-Jan-2020 NA NA Change
[7447-39-4].
to:
[10125-13-0].
2,5-DIHYDROXYBENZOIC ACID REAGENTS AND REFERENCE TABLES/Reagent Specifications USP42–NF37 6097 1-Dec-2019 NA NA Change
[303-07-1].
to:
[490-79-9].
<1430.5> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—SMALL ANGLE X-RAY SCATTERING AND SMALL ANGLE NEUTRON SCATTERING 6. EXPERIMENTAL CONSIDERATIONS Second Supplement to USP42–NF37 Online 1-Dec-2019 NA NA In 6.2 Resolution/6.2.1 Size resolution: Change
qmin < π/dmax π/dmax
to:
qmin < π/dmax
SIMVASTATIN TABLETS PERFORMANCE TESTS/Dissolution <711> USP42–NF37 4009 1-Dec-2019 NA NA In Standard solution: Change
USP Simvastatin RS in Medium
to:
USP Simvastatin RS in Medium. Transfer a portion of the solution to a centrifuge tube containing about 10 mg of Prewashed manganese dioxide per milliliter of… Read More
<1227> VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES VALIDATION OF NEUTRALIZATION METHODS—RECOVERY COMPARISONS Second Supplement to USP42–NF37 9616 1-Dec-2019 NA NA In paragraph 1 in Recovery on Agar Medium: Change
If it is necessary to solubilize the test stample,
to:
If it is necessary to solubilize the test sample,
MEFENAMIC ACID CAPSULES PERFORMANCE TESTS/Dissolution <711> USP42–NF37 2711 1-Dec-2019 NA NA Change
Solution A, Mobile phase, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay, making any necessary volumetric adjustments.
to:
Read More
0.1 N POTASSIUM HYDROXIDE VS REAGENTS AND REFERENCE TABLES/Solutions USP42–NF37 6185 1-Dec-2019 NA NA Change
Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N potassium hydroxide VS. Titrate with 0.1 N hydrochloric acid VS until a permanent pale-pink color is produced.
to:
Standardization: Add 2 drops of phenolphthalein TS… Read More
ROPINIROLE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official July 01, 2019) Online 1-Dec-2019 NA NA In Test 2 and Test 3 in Analysis: Change
Result1 = C1 × (1/L) × (Mr1/Mr2) × 100
to:
Result1 = C1 × V × (1/L… Read More
ZIPRASIDONE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Test 3/Tier 2 Revision Bulletin (Official October 01, 2019) Online 1-Dec-2019 NA NA In Buffer: Change
6.8 g/L g
to:
6.8 g/L
AND
In Standard stock solution 2: Change
Standard stock solution
to:
Standard stock solution 1
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL 1. OVERVIEW: GENERAL CHAPTERS BASED ON SCATTERING PHENOMENA Second Supplement to USP42–NF37 9634 1-Dec-2019 NA NA In Row 6 of Column 4 in Table 1: Change
Also properties of condensated phrases
to:
Also properties of condensated phases
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS IMPURITIES/Organic Impurities Second Supplement to USP42–NF37 9101 1-Dec-2019 NA NA In Table 4, Footnote h: Change
0.47,
to:
0.45,