Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
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OIL- AND WATER-SOLUBLE VITAMINS TABLETS | STRENGTH | USP40–NF35 | 7318 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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 | 28-Jul-2017 | 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
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<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS | SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating Instructions | USP40–NF35 | 216 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 26-May-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 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 | 31-Mar-2017 | 1-Apr-2017 | USP41–NF36 | USP41–NF36 | Bottom right corner of Figure 1:Change VHC mouthpiece to: Spacer mouthpiece |