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PDF CSV September 15, 2023 through September 15, 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
OIL- AND WATER-SOLUBLE VITAMINS TABLETS STRENGTH USP40–NF35 7318 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 16 of Sample solution: Change
Dilute a 10-mL volume of this solution
to:
Sample solution: Dilute a 10-mL volume of the Sample… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH USP40–NF35 7336 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 23 of Vitamin A, Method 1/Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the… Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP40–NF35 7375 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A, Method 1/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 16 of Sample solution: Change
Dilute a 10-mL volume of this solution
to:
Sample solution: Dilute a 10-mL volume of the Sample… Read More
SHELLAC IMPURITIES/Limit of Chloride USP40–NF35 7869 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Control solution: Change
0.1 M hydrochloric acid VS,
to:
0.01 M hydrochloric acid VS,
<210> MONOSACCHARIDE ANALYSIS PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids First Supplement to USP40–NF35 8059 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 6 of Analysis: Change
(1 M = 1nmol/mL).
to:
(1 µM = 1nmol/mL).
ACETAMINOPHEN AND CODEINE PHOSPHATE CAPSULES PERFORMANCE TESTS First Supplement to USP40–NF35 8201 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the Calculate statement of Uniformity of Dosage Units <905>/Procedure for content… Read More
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PERFORMANCE TESTS First Supplement to USP40–NF35 8202 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the second Calculate statement in Uniformity of Dosage Units <905>/Procedure for… Read More
ERYTHROMYCIN OPHTHALMIC OINTMENT ASSAY/Procedure/Analysis First Supplement to USP40–NF35 8276 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 9 of the third variable definition list: Change
P = potency of erythromycin C in USP Erythromycin B RS (mg/mg)
to:
P = potency of erythromycin C in USP Erythromycin C RS (mg/mg)
LEVOTHYROXINE SODIUM TABLETS IMPURITIES/Limit of Liothyronine Sodium First Supplement to USP40–NF35 8328 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 4 of Analysis: Change
Calculate the percentage of levothyroxine sodium (C15H11I3NNaO4)
to:
Calculate the percentage of liothyronine sodium (C15H11I3NNaO4)
NEOTAME ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP40–NF35 8485 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Neotame Related Compound A RS: Change
N-[3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine.
to:
N-[N-(3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine.
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS OTHER COMPONENTS/Content of Potassium Revision Bulletin (Official April 01, 2017) Online 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Sample solution: Change
Transfer 3.0 mL of the clear filtrate, reserved from the Assay, to a 100-mL volumetric flask.
to:
Sample stock solution: Dilute the clear filtrate, reserved from the Assay, with water to obtain a solution containing about 160… Read More
TIMOLOL MALEATE MULTIPLE SECTIONS Second Supplement to USP40–NF35 Online 1-Aug-2017 USP41–NF36 USP41–NF36 The version of the Timolol Maleate monograph which appeared in the Second Supplement to USP 40–NF 35 did not include the revisions approved in the version appearing in the First Supplement to USP 40–NF 35. The version appearing in the First Supplement should be used. The file… Read More
<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating Instructions USP40–NF35 216 1-Jun-2017 USP41–NF36 USP41–NF36 Column 4 for Step 6: Add
• For counting bead enumeration, proceed to either Step 7 or Step 8 according to the recommendations of the bead manufacturer.
<212> OLIGOSACCHARIDE ANALYSIS SEPARATION AND IDENTIFICATION OF OLIGOSACCHARIDES USP40–NF35 273 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1 of Normal Phase Chromatography/HILIC/Ammonium formate buffer: Change
Add 1.4 M ammonia solution to 1.4 M formic acid solution.
to:
Add 1.4 M ammonia solution to 1.4 M formic acid solution until a pH of 4.4 is obtained.
<603> TOPICAL AEROSOLS DELIVERED-DOSE UNIFORMITY USP40–NF35 499 1-Jun-2017 USP41–NF36 USP41–NF36 Line 2: Change
proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>,
to:
proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality… Read More
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL APPENDICES/Appendix 1: Regulations and Standards USP40–NF35 1471 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1 of bullet 1: Change
"Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms" (1993)
to:
"Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens" (2005)
ACETYLCYSTEINE SOLUTION ASSAY/Procedure USP40–NF35 2586 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of Sample solution: Change
Standard stock solution
to:
Sample stock solution
CONSTRUCT HUMAN FIBROBLASTS IN BILAYER SYNTHETIC SCAFFOLD SPECIFIC TESTS/Metabolic Activity Assessment USP40–NF35 3561 1-Jun-2017 USP41–NF36 USP41–NF36 Line 2 of L-Glutamine solution: Change
29.2 g
to:
2.92 g
GLUCONOLACTONE ASSAY/Procedure USP40–NF35 4412 1-Jun-2017 USP41–NF36 USP41–NF36 Line 5 of Analysis: Change
Each mL of Back-titrant
to:
Each milliliter of Titrant
IOHEXOL IMPURITIES/Limit of Free Iodide/Analysis USP40–NF35 4649 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of variable definition list: Change
0.1269 mg/mEq
to:
126.9 mg/mEq
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION ASSAY/Procedure USP40–NF35 5251 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of Sample solution: Change
45-µm pore size.
to:
0.45-µm pore size.
PHENYTOIN ORAL SUSPENSION IMPURITIES/Organic Impurities USP40–NF35 5690 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1 of Sample solution: Change
1 mg/mL of Oral Suspension in Diluent
to:
Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about 20% of the final flask volume… Read More
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 2 USP40–NF35 5720 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of Standard solution: Change
USP Metformin Hydrochloride RS in Diluent A
to:
USP Metformin Hydrochloride RS from the Metformin standard stock solution in Diluent A
POLYETHYLENE GLYCOL 3350 SPECIFIC TESTS/Apparent Weight-Average Molecular Weight and Polydispersity USP40–NF35 5745 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1 of Standard solution: Change
Standard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solution
to:
Standard solutions: Prepare 1.0… Read More
SCAFFOLD BOVINE DERMIS SPECIFIC TESTS USP40–NF35 6113 1-Jun-2017 USP41–NF36 USP41–NF36 Line 5 of Carbohydrate Content/Acceptance criteria: Change
Moisture Content
to:
Loss on Drying
AND
Line 3 of Suture Retention Force/Analysis: Change
40
to:
4-0
EVENING PRIMROSE OIL CAPSULES STRENGTH/Analysis USP40–NF35 6952 1-Jun-2017 USP41–NF36 USP41–NF36 In the first variable definition list: Change
mS = weight of USP Methyl Ester RS in the Standard solution (mg)
to:
mS = weight of the relevant USP Methyl Ester RS in the Standard solution (mg)
SUCROSE SPECIFIC TESTS/Color Value/Analysis USP40–NF35 7938 1-Jun-2017 USP41–NF36 USP41–NF36 Line 6 of the variable definition list: Change
The absolute difference between two results is NMT 3.
to:
Suitability requirements
Repeatability: The absolute difference between two results is NMT 3.
METHIONINE IMPURITIES/Related Compounds First Supplement to USP40–NF35 8337 1-Jun-2017 USP41–NF36 USP41–NF36 Row 5 of Column 3 of Table 2: Change
0.1
to:
1.0
METHYLDOPA ASSAY/Procedure/Chromatographic system First Supplement to USP40–NF35 8339 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1 of Injection volume: Change
1 mL
to:
20 µL
TIMOLOL MALEATE IDENTIFICATION/B. First Supplement to USP40–NF35 8416 1-Jun-2017 USP41–NF36 USP41–NF36 Line 1: Change
major peak of the Sample solution corresponds to that of the Standard solution,
to:
timolol peak of the Sample solution corresponds to that of the System suitability solution,
TIMOLOL MALEATE IMPURITIES/Enantiomeric Purity First Supplement to USP40–NF35 8416 1-Jun-2017 USP41–NF36 USP41–NF36 Line 6 of Chromatographic system: Delete
Autosampler temperature: 4°
DOCETAXEL IMPURITIES/Organic Impurities, Procedure 1 Revision Bulletin (Official August 01, 2016) Online 1-Jun-2017 USP41–NF36 USP41–NF36 Footnote c of Table 2: Change
(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b… Read More
DOBUTAMINE INJECTION IDENTIFICATION/A. USP39–NF34 3561 1-Apr-2017 USP41–NF36 USP41–NF36 Line 1 of Sample solution: Change
10 mg/mL of dobutamine hydrochloride in methanol, clarified by centrifugation
to:
Use the neat Injection.
EZETIMIBE IMPURITIES/Organic Impurities, Procedure 1/System suitability/Suitability requirements USP39–NF34 3840 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of Resolution: Change
Standard solution
to:
System suitability solution
MYCOPHENOLATE MOFETIL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4957 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of USP Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7
MYCOPHENOLATE MOFETIL FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4960 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7
MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 4961 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Mycophenolate Mofetil Related Compound A RS: Change
C23H31NO7
to:
C22H29NO7
SORBITOL SOLUTION ASSAY/Procedure/Analysis USP39–NF34 5897 1-Apr-2017 USP41–NF36 USP41–NF36 In the variable definition list: Change
CU = nominal concentration of Sorbitol Solution in the Sample solution (mg/g)
to:
CU = concentration of Sorbitol Solution in the Sample solution (mg/g)
VINORELBINE TARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 6370 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.
VINORELBINE INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP39–NF34 6371 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of USP Vinorelbine Related Compound A RS: Change
4-O-Deacetylvinorelbine.
to:
4-O-Deacetylvinorelbine tartrate.
POWDERED MILK THISTLE EXTRACT COMPOSITION/Content of Silymarin USP39–NF34 6764 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
MILK THISTLE CAPSULES STRENGTH/Content of Silymarin USP39–NF34 6765 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
MILK THISTLE TABLETS STRENGTH/Content of Silymarin USP39–NF34 6767 1-Apr-2017 USP41–NF36 USP41–NF36 Row 2 of Column 2 of Table 1: Change
0
to:
85
AND
Row 2 of Column 3 of Table 1: Change
0
to:
15
MAGNESIUM ALUMINOMETASILICATE ASSAY/Magnesium Oxide USP39–NF34 7375 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Analysis: Change
eriochrome black TS trituration
to:
eriochrome black T trituration
MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities First Supplement to USP39–NF34 8101 1-Apr-2017 USP41–NF36 USP41–NF36 Change
Buffer, Mobile phase, Diluent, and Sample solution: Prepare as directed in the Assay.
to:
Buffer, Mobile phase, and Diluent: Prepare as directed in the Assay.
AND
Add
Sample solution: Use the Sample… Read More
REAGENTS, INDICATORS AND SOLUTIONS Solutions/Volumetric Solutions Second Supplement to USP39–NF34 8458 1-Apr-2017 USP41–NF36 USP41–NF36 Line 3 of 0.07 N Ferrous Ammonium Sulfate VS: Change
In a 100-mL volumetric flask,
to:
In a 1000-mL volumetric flask,
MAGNESIUM ALUMINUM SILICATE SPECIFIC TESTS/Viscosity/Acceptance criteria Second Supplement to USP39–NF34 8558 1-Apr-2017 USP41–NF36 USP41–NF36 Line 1 of Type IA: Change
225–600
to:
225–600mPa · s
AND
Line 1 of Type IB: Change
150–450
to:
150–450 mPa · s
AND
Line 1 of Type IC: Change
800–2200
to:
800–2200 mPa · s
AND
Line 1 of Type IIA: Change
100–300
to:
Read More
ROPINIROLE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities/Analysis Second Supplement to USP39–NF34 8814 1-Apr-2017 USP41–NF36 USP41–NF36 Line 8 of the variable definition list of the first equation: Change
CU = nominal concentration of ropinirole related compound B free base in the Sample solution (µg/mL)
to:
CU = nominal concentration of ropinirole in the Read More
<481> RIBOFLAVIN ASSAY ASSAY USP40–NF35 386 1-Apr-2017 USP41–NF36 USP41–NF36 Line 2 of the variable definition list in Chemical Methods, Procedure 1/Analysis: Change
sodium hydrofluorite
to:
sodium hydrosulfite
<1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS—CHARACTERIZATION TESTS 1. INTRODUCTION/1.5 Definitions of Key Terms Relating to This Chapter USP40–NF35 1988 1-Apr-2017 USP41–NF36 USP41–NF36 Bottom right corner of Figure 1:Change
VHC mouthpiece
to:
Spacer mouthpiece