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PDF CSV April 3, 2023 through April 3, 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
<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
MENADIONE ASSAY/Procedure USP43–NF38 2780 1-May-2020 NA NA In Endpoint detection: Change
Potentiometric
to:
Visual
<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
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
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
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
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
ANTITHROMBIN III HUMAN ADDITIONAL REQUIREMENTS USP42–NF37 350 1-Apr-2020 NA NA In Labeling: Change
USP Antithrombin III Units.
to:
Antithrombin III IU.
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
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
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
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
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].
<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
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,
25% TETRABUTYLAMMONIUM HYDROXIDE TS REAGENTS AND REFERENCE TABLES/Solutions Second Supplement to USP42–NF37 9336 1-Dec-2019 NA NA Change
Transfer about 34.82 g
to:
Transfer about 77.1 g
SODIUM BICARBONATE IMPURITIES/Carbonate/Analysis USP42–NF37 Online 1-Dec-2019 NA NA Remove the external reference to a reagent in
Sodium Bicarbonate
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
<1228.4> DEPYROGENATION BY RINSING ROUTINE PROCESS CONTROL USP42–NF37 8067 1-Nov-2019 NA NA In the first paragraph: Change
WFI
to:
Water for Injection
<55> BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS D-VALUE DETERMINATION USP42–NF37 6385 1-Nov-2019 NA NA In the third paragraph in Procedure: Change
stated spore filter
to:
stated spore titer
GADOTERIDOL Limit of gadoteridol related compound A USP42–NF37 2020 1-Nov-2019 NA NA In Chromatographic system: Change
packing L21
to:
packing L47
<1229.2> STEAM STERILIZATION OF AQUEOUS LIQUIDS BIOBURDEN/BIOLOGICAL INDICATOR METHOD/Routine Process Control USP42–NF37 8082 1-Nov-2019 NA NA In the first paragraph: Change
calibrartion
to:
calibration
<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE INTRODUCTION USP42–NF37 8021 1-Nov-2019 NA NA In paragraphs 4 and 5: Change
a probability of a PNSU
to:
a PNSU
HYPROMELLOSE ACETATE SUCCINATE ASSAY USP42–NF37 5772 1-Nov-2019 NA NA In Content of Methoxy and 2-Hydroxypropoxy Groups/Analysis: Change
Result = (rUM/rSM) × (CS/CU) × (Mr1/Mr2)
to:
Result… Read More
<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS BUFFER AND MEDIA/Media USP42–NF37 8514 1-Nov-2019 NA NA In Row 5 of Column 2 for L-Cystine in Fluid Selenite–Cystine Medium: Change
10.0 g
to:
10.0 mg
AMIODARONE HYDROCHLORIDE CHEMICAL INFORMATION USP42–NF37 253 1-Oct-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/september-2019-errata-with-image.pdf for correction.
DESFLURANE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP42–NF37 1230 1-Oct-2019 NA NA In USP Desflurane Related Compound A RS: Change
Bis-(1,2,2,2-tetrafluoroethyl)ether.
to:
Bis-(1,2,2,2-tetrafluoroethyl)ether;
Also known as: 1,1,1,2-Tetrafluoro-2-(1,2,2,2-tetrafluoroethoxy)ethane.
BENZALDEHYDE ASSAY/Procedure USP42–NF37 5586 1-Oct-2019 NA NA In Chromatographic system: Delete
Detector temperature: 25°