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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 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
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
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
<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.
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
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
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
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
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
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.
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
<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
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
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
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,
<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.
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
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
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
<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)
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.
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)
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°
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
DESLORATADINE ORALLY DISINTEGRATING TABLETS IMPURITIES/Organic Impurities First Supplement to USP40–NF35 Online 1-Apr-2017 USP41–NF36 USP41–NF36 Line 5 of Sample solution: Change
Add 70% of the flask volume of Mobile phase
to:
Add 70% of the flask volume of Diluent
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
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
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,
PENICILLIN G PROCAINE SPECIFIC TESTS/Content of Penicillin G and Procaine/Analysis USP40–NF35 5607 1-Apr-2017 USP41–NF36 USP41–NF36 Line 7 of the variable definition list for the first equation: Change
CU = concentration of Penicillin G Procaine in the Sample solution (mg)
to:
CU = concentration of Penicillin G Procaine in the Sample solution (mg/mL)
Read More
ALMOTRIPTAN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official February 01, 2017) Online 1-Apr-2017 USP41–NF36 USP41–NF36 Line 4 of USP Almotriptan Related Compound B RS: Change
½C4H4O
to:
½C4H4O4
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
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.
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
<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
GRANISETRON HYDROCHLORIDE INJECTION USP Reference standards <11> First Supplement to USP40–NF35 Online 1-Apr-2017 USP41–NF36 USP41–NF36 Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.
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
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
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
RINGER'S INJECTION ASSAY USP40–NF35 6019 1-Apr-2017 USP41–NF36 USP41–NF36 Line 1 of Calcium/Instrumental conditions/Mode: Change
spectrophotometer
to:
spectrophotometry
AND
Line 1 of Potassium/Solution A: Change
Suitable wetting agent
to:
Suitable nonionic wetting agent
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
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.
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
<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
GRANISETRON HYDROCHLORIDE TABLETS USP Reference standards <11> First Supplement to USP40–NF35 Online 1-Apr-2017 USP41–NF36 USP41–NF36 Line 3 of USP Granisetron Related Compound C RS: Change
carboxamide.
to:
carboxamide hydrochloride.
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.
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)
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
ADAPALENE GEL ASSAY/Procedure First Supplement to USP39–NF34 7983 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 5 of Sample stock solution: Change
Cool to room temperature and dilute with Diluent to volume.
to:
Cool to room temperature and dilute with Mobile phase to volume.
PROMETHAZINE HYDROCHLORIDE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP39–NF34 8788 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Promethazine Related Compound B RS: Change
Isopromethazine;
N,N-Dimethyl-2-(10H-phenothiazin-10-yl)propan-1-amine.
C17H20N2S 284.42
to:
Isopromethazine hydrochloride;
N,N-Dimethyl-2-(10H-… Read More
AMINOPHYLLINE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP40–NF35 2735 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2 of USP Theophylline Related Compound D RS: Change
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide.
C6H10N4O 154.17
to:
Theophyllidine;
N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride… Read More