Skip to main content

Errata - English

CSV September 23, 2015 through September 23, 2017 See all Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Official Date Sort ascending Target Errata Print Publication Target Online Fix Publication Description
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… 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… Read More
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… Read More
OIL- AND WATER-SOLUBLE VITAMINS CAPSULES STRENGTH USP40–NF35 7290 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 Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the Read More
OIL-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP40–NF35 7280 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 15 of Sample solution: Change
Further dilute this solution
to:
Sample solution: Dilute the Sample stock solutionRead More
OIL-SOLUBLE VITAMINS WITH MINERALS CAPSULES STRENGTH USP40–NF35 7265 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Vitamin A/Sample solution: Change
Sample solution
to:
Sample stock solution
AND
Line 21 of Sample solution: Change
Further dilute this solution
to:
Sample solution: Dilute the Sample stock solutionRead More
OIL-SOLUBLE VITAMINS TABLETS STRENGTH USP40–NF35 7258 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… Read More
OIL-SOLUBLE VITAMINS CAPSULES STRENGTH USP40–NF35 7248 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 Sample solution: Change
Dilute a volume of this solution
to:
Sample solution: Dilute a volume of the 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
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,
ROCURONIUM BROMIDE IMPURITIES/Limit of 2-Propanol/Analysis USP40–NF35 6066 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of the variable definition list: Change
rU = peak response of any impurity from the Sample solution
rS = peak response of rocuronium bromide from the Dilute standard solution
to:
rURead More
PROPANTHELINE BROMIDE IMPURITIES/Organic Impurities/Chromatographic system USP40–NF35 5882 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Run time: Change
NMT
to:
NLT
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… Read More
PERPHENAZINE IMPURITIES/Organic Impurities/Chromatographic system USP40–NF35 5649 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Column: Change
4.6-mm
to:
4.0-mm
ONDANSETRON TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 5445 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Ondansetron Related Compound A RS: Change
3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
to:
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
ONDANSETRON ORAL SOLUTION USP Reference standards <11> USP40–NF35 5444 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Ondansetron Related Compound A RS: Change
3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
to:
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
ONDANSETRON INJECTION USP Reference standards <11> USP40–NF35 5443 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Ondansetron Related Compound A RS: Change
3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
to:
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
ONDANSETRON HYDROCHLORIDE USP Reference standards <11> USP40–NF35 5441 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 2 of USP Ondansetron Related Compound A RS: Change
3[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one.
to:
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
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.
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)
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)
DOXAZOSIN MESYLATE ASSAY/Procedure/System suitability/Suitability requirements USP40–NF35 3874 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Resolution: Change
NLT 4
to:
NLT 2
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>/Read More
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… Read More
<581> VITAMIN D ASSAY ASSAY/Chromatographic Methods/Procedure 8 USP40–NF35 462 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Clean-up chromatographic system: Add
Flow rate: 1.1 mL/min
AND
Analytical chromatographic system: Add
Flow rate: 1.0 mL/min
<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).
G49 CHROMATOGRAPHIC COLUMNS/Packings First Supplement to USP40–NF35 8127 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Add
G49—Dimethylpolysiloxane with chiral building block containing D- or L-valine as chiral agent (for amino acids).
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°
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,
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.
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
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… 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
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… Read More
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.
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
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
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
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
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)
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… Read More
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
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
<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)
<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… Read More
<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.
<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.
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.
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.
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)