Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
STEAROYL POLYOXYLGLYCERIDES | IMPURITIES/Limit of Free Glycerol | USP36–NF31 | 2250 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 11 of Analysis: Change (VS − VB) to: (VB − VS) AND Line 12 of Analysis: Change VS = Titrant volume consumed by the Sample… Read More |
<232> ELEMENTAL IMPURITIES—LIMITS | ANALYTICAL TESTING | USP36–NF31 | 151 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2: Change If, by validated processes and supply-chain control, to: If, by process monitoring and supply-chain control, |
CARISOPRODOL, ASPIRIN, AND CODEINE PHOSPHATE TABLETS | USP Reference standards <11> | USP36–NF31 | 2813 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2 of USP Codeine N-Oxide RS: Change C18H21O4 to: C18H21NO4 |
CAPRYLOCAPROYL POLYOXYLGLYCERIDES | IMPURITIES/Limit of Free Glycerol | USP36–NF31 | 1922 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Mode in Titrimetric system: Change Direct titration to: Residual titration AND Line 10 of Analysis: Change (VT − VB) to: (VB − VS) AND… Read More |
FERUMOXSIL ORAL SUSPENSION | Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> | USP36–NF31 | 3572 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1: Change and to: or |
FERROSOFERRIC OXIDE | IMPURITIES | USP36–NF31 | 2018 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Sample solution C in Limit of Lead (Pb): Change Sample solution to: Sample stock solution AND Line 1 of Sample solution D in Limit of Lead (Pb): Change Sample solution to: Sample stock solution AND Line… Read More |
POLYVINYL ALCOHOL | SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911>, Rotational Rheometer Methods <912>, and Rolling Ball Viscometer Method <913> | USP36–NF31 | 4830 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2: Change and to: or |
OLEOYL POLYOXYLGLYCERIDES | IMPURITIES/Limit of Free Glycerol | USP36–NF31 | 2112 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Mode in Titrimetric system: Change Direct titration to: Residual titration AND Line 10 of Analysis: Change (VS − VB) to: (VB − VS) AND Line 11 of Analysis:… Read More |
SALICYLIC ACID | USP Reference standards <11> | USP36–NF31 | 5098 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 3 of USP Salicylic Acid Related Compound A RS: Change [CAS-99-96-7]. to: [99-96-7]. AND Line 3 of USP Salicylic Acid Related Compound B RS: Change C8H6O4 to: C8H6O5 |
POTASSIUM METAPHOSPHATE | SPECIFIC TESTS/Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> | USP36–NF31 | 2172 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1: Change and to: or |
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS | IMPURITIES/Organic Impurities, Procedure 2 | First Supplement to USP36–NF31 | 5996 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 3: Change the section head Isosorbide mononitrate related compound A stock solution: to: Isosorbide mononitrate related compound A standard stock solution: AND Line 7: Change the section head Isosorbide dinitrate stock solution: to: Isosorbide… Read More |
SORBITAN SESQUIOLEATE | IDENTIFICATION/A. | USP36–NF31 | 2215 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Sample: Change 1 g of the residue obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 192–204 to: 192–204 on 1-g sample |
PANCURONIUM BROMIDE INJECTION | IMPURITIES/Organic Impurities | Second Supplement to USP36–NF31 | 6677 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Footnote a of Table 1: Change Piperidinium, 1-[(2,3,5,16,17)-17-acetyloxy-3-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methyl bromide. to: Piperidinium, 1-[(2,3,5,16,17)-17-acetyloxy-3-hydroxy-2-(1-piperidinyl)androstan-16-yl]-1-methyl. |
CAFFEINE CITRATE INJECTION | Assay | USP36–NF31 | 2732 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 3 of Chromatographic system: Change 150-cm column to: 15-cm column |
BEHENOYL POLYOXYLGLYCERIDES | IMPURITIES/Limit of Free Glycerol/Titrimetric system | USP36–NF31 | 1892 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Mode: Change Direct titration to: Residual titration |
ESOMEPRAZOLE MAGNESIUM | SPECIFIC TESTS/Color of Solution | USP36–NF31 | 3464 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Sample solution: Change 20 mg/mL of Esomeprazole Magnesium in methanol to: 20 mg/mL of Esomeprazole Magnesium in methanol, filtered |
EGG PHOSPHOLIPIDS | ASSAY/Content of Phospholipids | USP36–NF31 | 2000 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2 of Solution A: Change acetic acid to: glacial acetic acid AND Line 2 of Solution B: Change acetic acid to: glacial acetic acid |
OCTOCRYLENE | Identification, Ultraviolet Absorption <197U> | USP36–NF31 | 4557 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 4: Change Absorptivities, calculated on the as-is basis, to: Absorptivity at 303 nm, calculated on the as-is basis, |
LAUROYL POLYOXYLGLYCERIDES | IMPURITIES/Limit of Free Glycerol | USP36–NF31 | 2064 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Mode in Titrimetric system: Change Direct titration to: Residual titration AND Line 10 of Analysis: Change (VS − VB) to: (VB − VS) AND Line 11 of Analysis:… Read More |
RIMEXOLONE OPHTHALMIC SUSPENSION | Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> | USP36–NF31 | 5053 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1: Change and to: or |
POLYOXYL 20 CETOSTEARYL ETHER | SPECIFIC TESTS/Average Polymer Length | USP36–NF31 | 2155 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 16 of Analysis: Change Result = [32 × A2/(A1 − 3)]/4 to: Result = [(32 × A2/A1) − 3]/4 |
URSODIOL TABLETS | IMPURITIES/Organic Impurities/Procedure | USP36–NF31 | 5520 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2 of Sample solution: Change Tablets, equivalent to about 25 mg of ursodiol, to: Tablets, equivalent to about 250 mg of ursodiol, |
SORBITAN MONOPALMITATE | IDENTIFICATION/A. | USP36–NF31 | 2213 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Sample: Change 1 g of the residue obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 210–225 to: 210–225 on 1-g sample |
BETHANECHOL CHLORIDE | IMPURITIES/Heavy Metals, Method 1 <231> | Second Supplement to USP36–NF31 | 6568 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Test preparation: Change Bethacholine Chloride to: Bethanechol Chloride |
STEARYL ALCOHOL | SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> | USP36–NF31 | 2252 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 14 of Analysis: Change [(VS − VB) × N × F]/W to: [(VB − VS) × N × Mr]/W AND Line 15 of Analysis: Change… Read More |
ACETYLTRIBUTYL CITRATE | IDENTIFICATION/B. | USP36–NF31 | 1869 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2: Change USP Acetyltriethyl Citrate RS to: USP Acetyltributyl Citrate RS |
CLAVULANATE POTASSIUM | IMPURITIES/Organic Impurities/Procedure 3: Limit of Aliphatic Amines | USP36–NF31 | 3022 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | In the definition list in Analysis: Change CU = nominal concentration of Clavulanate Potassium in the Standard solution to: CU = nominal concentration of Clavulanate Potassium in the Sample solution |
CETOSTEARYL ALCOHOL | SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> | USP36–NF31 | 1954 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Mode in Titrimetric system: Change Direct titration to: Residual titration AND Line 16 of Analysis: Change Result = [(VS − VB) × F]/W to: Result = [(VB… Read More |
MERCAPTOPURINE TABLETS | IMPURITIES/Organic Impurities/Procedure | USP36–NF31 | 4249 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 6 of Sample stock solution: Change Dilute with water to volume. to: Dilute with Solution A to volume. |
GLYCERYL MONOLINOLEATE | ASSAY/Procedure | USP36–NF31 | 2030 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 13 of Chromatographic system: Change Column temperature: 40° to: Temperatures Detector: 40° Column: 40° |
QUININE SULFATE | IMPURITIES/Dihydroquinine Sulfate | USP36–NF31 | 4995 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 5 of Analysis: Change Result = (rU/rS) × 100 to: Result = rU/(rU + rS) × 100 |
POLYISOBUTYLENE | IMPURITIES/Lead <251> | USP36–NF31 | 2149 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Acceptance criteria: Change NMT 3 mg/g to: NMT 3 μg/g |
TERAZOSIN CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Test 1/Spectrometric conditions | USP36–NF31 | 5308 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Analytical wavelength: Change UV 245 nm to: UV 246 nm AND Line 3 of Cell length: Change 0.2 cm for Capsules labeled to contain 10 mg to: 0.5 cm for Capsules labeled to contain 10 mg |
SORBITAN MONOLAURATE | IDENTIFICATION/A. | USP36–NF31 | 2212 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Sample: Change 1 g of the residue obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 260–280 to: 260–280 on 1-g sample |
LOPINAVIR AND RITONAVIR TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP36–NF31 | 6005 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Tolerances: Change 80.0% to: 80% |
SORBITAN TRIOLEATE | IDENTIFICATION/A. | USP36–NF31 | 2216 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Sample: Change 1 g of the residue of oleic acid obtained in the Assay for Fatty Acids to: Residue obtained in the Assay for Fatty Acids AND Line 2 of Acceptance criteria: Change 192–204 to: 192–204 on 1-g sample |
POLYMYXIN B SULFATE | IMPURITIES/Organic Impurities | Second Supplement to USP36–NF31 | 6686 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2: Change Buffer, Mobile phase, Diluent, Sensitivity solution, to: Buffer, Mobile phase, Diluent, Standard solution, Sensitivity solution, AND Line 1 of Samples in Analysis: Change Standard solution, Sample solution, and … Read More |
<232> ELEMENTAL IMPURITIES—LIMITS | DRUG PRODUCTS/Options for Demonstrating Compliance | USP36–NF31 | 151 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 17 of Summation Option: Change the manufacturer must validate to: the manufacturer must ensure |
CAFFEINE CITRATE ORAL SOLUTION | Assay | USP36–NF31 | 2733 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 3 of Chromatographic system: Change 150-cm column to: 15-cm column |
BETADEX | IMPURITIES/Limit of Reducing Sugars | USP36–NF31 | 1905 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 3 of Tartrate solution: Change 20 mg/mL of anhydrous sodium sulfate to: 200 mg/mL of anhydrous sodium sulfate |
ETHIODIZED OIL INJECTION | Viscosity—Capillary Viscometer Methods <911> and Rotational Rheometer Methods <912> | USP36–NF31 | 3505 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1: Change and to: or |
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION | Assay | USP36–NF31 | 3276 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2: Change Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride. to: Mobile phase—Prepare a solution of acetonitrile, water,… Read More |
FEXOFENADINE HYDROCHLORIDE TABLETS | ASSAY/Procedure | USP36–NF31 | 3576 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 6 of Sample stock solution: Change (equivalent to 80% of the total flask volume) to: (sufficient to fill the flask to 80% of its volume) |
NIFEDIPINE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 4/Instrumental conditions | USP36–NF31 | 4509 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Cell: Change 0.5 cm to: 1 cm |
GYMNEMA | IDENTIFICATION/B. Thin-Layer Chromatography/Chromatographic system | First Supplement to USP36–NF31 | 5880 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2 of Adsorbent: Change 5m to: 5 µm |
POWDERED STINGING NETTLE EXTRACT | COMPOSITION/Content of Total Amino Acids | USP36–NF31 | 1608 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Reagent solution: Change Solution containing 1.00 g of ninhydrin, 1.50 g of hydrindantin, to: Solution containing 1.00 g of ninhydrin, 150 mg of hydrindantin, |
OXCARBAZEPINE | IMPURITIES/Organic Impurities, Procedure 1 | First Supplement to USP36–NF31 | 6035 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Row 4 of Column 1 of Table 1: Change Dibenzazepinoneb to: Oxcarbazepine related compound E AND Delete footnote b AND Reletter the following footnotes in both the table and footnote definitions: c to b d to c e to d |
CALCIUM CARBONATE | IMPURITIES | USP36–NF31 | 2747 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 1 of Acceptance criteria in Limit of Fluoride: Change 50 ppm to: NMT 50 ppm AND Line 1 of Acceptance criteria in Mercury, Method IIa <261>: Change 0.5 ppm to: NMT 0.5 ppm |
CRYOPRESERVED HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE | Total collagen content | USP36–NF31 | 3155 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 7 of Collagen calibration standards: Change by adding 25 mL, 50 mL, 100 mL, and 200 mL, to: by adding 25 μL, 50 μL, 100 μL, and 200 μL, |
EDETATE DISODIUM | ASSAY/Procedure | USP36–NF31 | 3370 | 26-Jul-2013 | 1-Aug-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 16 of Analysis: Change Calculate the percentage of edetate disodium to: Calculate the weight of edetate disodium AND Line 19 of Analysis: Change Result = (VT/VU) × W × (Mr1/Mr2) ×… Read More |