Monograph Title | Section | Source Publication | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication Sort ascending | Description |
---|---|---|---|---|---|---|---|---|
PEMETREXED FOR INJECTION | ASSAY/Procedure/Analysis | First Supplement to USP41–NF36 | Online | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 8 of the variable definition list: Change Mr2 = molecular weight of pemetrexed disodium (anhydrous), 473.37 to: Mr2 = molecular weight of pemetrexed disodium (anhydrous), 471.38 |
SUMATRIPTAN NASAL SPRAY | ASSAY/Procedure | First Supplement to USP41–NF36 | Online | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | This erratum applies to the new USP-NF ONLINE platform only. In the variable definition in Analysis: Change CS = concentration of USP Sumatriptan Succinate Related Compound A RS to: CS = concentration of… Read More |
POWDERED ECHINACEA PALLIDA EXTRACT | IDENTIFICATION | USP40–NF35 | 6935 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More |
INSULIN LISPRO INJECTION | PRODUCT-RELATED SUBSTANCES AND IMPURITIES/Related Substances | USP41–NF36 | 2180 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 3 of Analysis: Change Calculate the percentage of insulin lispro, A-21 desamido insulin lispro, and other impurities in the portion of Insulin Lispro taken: to: Calculate the percentage of insulin lispro, A-21 desamido insulin lispro, and other… Read More |
VALERIAN | IDENTIFICATION/C. Thin-Layer Chromatography | USP40–NF35 | 7238 | 29-Dec-2017 | 1-Jan-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of Chromatographic system/Developing solvent system:Change acetic acid to: glacial acetic acid AND Line 2 ofChromatographic system/Derivatization reagent B: Change aceticacid to: glacial acetic acid |
<1661> EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT | APPLICABILITY AND APPLICATION OF <661.1> | USP41–NF36 | 7902 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of Application/4.: Change proscribed to: prescribed AND Line 3 of Description of Polymers Contained in <661.1>/Polyethylenes: Change Low-density polypropylene (LDPE) to: Low-density polyethylene (… Read More |
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 1447 | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 2 of USP Ethinyl Estradiol Related Compound B RS: Change 19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol. C20H22O2 294.39 to: 19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol… Read More |
QUETIAPINE EXTENDED-RELEASE TABLETS | IMPURITIES/Organic Impurities | Revision Bulletin (Official November 01, 2017) | Online | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Footnote a of Table 5: Change total impurities. to: total degradation products. AND Footnote b: Change total impurities. to: total degradation products. |
REAGENTS | REAGENTS, INDICATORS, AND SOLUTIONS/Reagent Specifications | USP41–NF36 | 5737 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 4 of N-(2-Tetrahydrofuroyl)piperazine: Change EMS-DOTTIKON, www.ems-dottikon.ch. to: Oakwood Chemical, www.oakwoodchemical.com. |
PURIFIED WATER | ADDITIONAL REQUIREMENTS | USP41–NF36 | 4347 | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Delete • USP Reference Standards <11> USP 1,4-Benzoquinone RS |
GLUTARAL CONCENTRATE | ASSAY/Procedure | USP40–NF35 | 4414 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 7 of Analysis: Change Add a weighed quantity of Concentrate containing 1.2 g of glutaral by means of a suitable weighing pipet. to: Add 1.2 g of Glutaral Concentrate. |
<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION | 3. ACCURACY AND PRECISION/3.1 Methods for Estimating Accuracy and Precision | USP41–NF36 | 7622 | 23-Feb-2018 | 1-Mar-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Paragraph 4: Change For example, with ɑ = 0.05 and n = 9, t0.95:8 = 1.860 provides a 100(1− 2 × 1.05)% to: For example, with ɑ = 0.05 and n = 9, t0.95:8 = 1.860 provides a 100(1 − 2 × 0.05)% |
ISOSORBIDE DINITRATE SUBLINGUAL TABLETS | Identification | USP41–NF36 | 2272 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1: Change Tablets respond to the Identification test under Isosorbide Dinitrate Tablets. to: Transfer a suitable quantity of finely powdered Tablets to a glass-stoppered centrifuge tube. Add 10 mL of sodium hydroxide solution (1 in… Read More |
NAPROXEN TABLETS | IMPURITIES/Organic Impurities | USP41–NF36 | 2865 | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 3 of System suitability solution: Change 0.5 mg/mL of USP Naproxen RS and 0.5 µg/mL of USP Naproxen Related Compound A RS in Diluent, from Standard stock solution 1 and Standard stock solution 2, respectively to: 0.5 µg/… Read More |
DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION | Identification | USP40–NF35 | 3866 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of A: Change It responds to the Identification test under Dextrose. to: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed. |
RACEPINEPHRINE INHALATION SOLUTION | ADDITIONAL REQUIREMENTS | USP41–NF36 | 3564 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Add USP Reference Standards <11> USP Epinephrine Bitartrate RS |
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION | ASSAY/Procedure | First Supplement to USP40–NF35 | 8299 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of Solution B: Change (0.5: 99.5) to: (0.05: 99.95) |
REPOSITORY CORTICOTROPIN INJECTION | ADDITIONAL REQUIREMENTS | USP41–NF36 | 1097 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In USP Reference Standards <11>: Add USP Ascorbic Acid RS |
CARBIDOPA AND LEVODOPA TABLETS | ASSAY/Procedure/Chromatographic system | USP41–NF36 | 693 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Detector: Change Identification B, to: Identification A, |
TRANYLCYPROMINE TABLETS | ASSAY/Procedure | First Supplement to USP41–NF36 | Online | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | This erratum applies to the new USP-NF ONLINE platform only. Change Mobile phase: Methanol and Buffer (30:70) Diluent: Methanol, water, and 0.05 N sulfuric acid ▲VS▲1S (USP41)… Read More |
ECHINACEA PURPUREA AERIAL PARTS | IDENTIFICATION | USP40–NF35 | 6937 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More |
MILRINONE LACTATE INJECTION | IMPURITIES/Organic Impurities | USP41–NF36 | 2748 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Equation in Analysis: Change Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100 to: Result = (rU… Read More |
POWDERED VALERIAN | IDENTIFICATION/C. Thin-Layer Chromatography | USP40–NF35 | 7240 | 29-Dec-2017 | 1-Jan-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of Chromatographic system/Developing solvent system:Change acetic acid to: glacial acetic acid AND Line 2 ofChromatographic system/Derivatization reagent B: Change aceticacid to: glacial acetic acid |
MICONAZOLE NITRATE TOPICAL POWDER | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP41–NF36 | 8355 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Miconazole Related Compound C RS: Change 2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine. C15H13Cl4NO 365.08 to: 2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine… Read More |
GUAIFENESIN | IMPURITIES/Organic Impurities | USP41–NF36 | 2001 | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | In the equation in Analysis: Change Result = (rU/rS) × (1/F) × 100 to: Result = (rU/rS) × (CS… Read More |
NIACIN EXTENDED-RELEASE TABLETS | ASSAY/Procedure | Revision Bulletin (Official January 01, 2018) | Online | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of System suitability: Change Table 4 to: Table 13 |
REAGENTS | CHROMATOGRAPHIC COLUMNS/Packings | USP41–NF36 | 5776 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 2 of L73: Delete [Note—Available as Jordi-Gel DBV from www.jordiflp.com.] |
STERILE PURIFIED WATER | ADDITIONAL REQUIREMENTS | USP41–NF36 | 4348 | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Delete • USP Reference Standards <11> USP 1,4-Benzoquinone RS |
HYDROXYZINE HYDROCHLORIDE | ASSAY/Procedure | USP40–NF35 | 4539 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of Solution B: Change (0.5: 99.5) to: (0.05: 99.95) |
AMLODIPINE AND ATORVASTATIN TABLETS | ASSAY/Procedure | First Supplement to USP41–NF36 | 8270 | 23-Feb-2018 | 1-Mar-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In the variable definition list of the second equation in Analysis: Change Mr2 = molecular weight of atorvastatin calcium, 1209.39 to: Mr2 = molecular weight of atorvastatin calcium, 1155.34 |
ISOSORBIDE DINITRATE SUBLINGUAL TABLETS | Assay | USP41–NF36 | 2272 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Change Buffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Diluted Isosorbide Dinitrate. to: Buffer… Read More |
PIOGLITAZONE AND GLIMEPIRIDE TABLETS | IMPURITIES/Organic Impurities: Glimepiride | USP41–NF36 | 3314 | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Change Table 3 to: Table 4 AND Change Table 4 to: Table 5 AND Line 1 of Mobile phase: Change Table 3 to: Table 4 AND In the variable definition list in… Read More |
ESZOPICLONE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP40–NF35 | 4090 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Eszopiclone Related Compound A RS: Change 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide. C17H17ClN6O4 404.81 to: [Note—This… Read More |
RACEPINEPHRINE HYDROCHLORIDE | USP Reference standards <11> | USP41–NF36 | 3565 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Add USP Epinephrine Bitartrate RS |
ALMOTRIPTAN TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP40–NF35 | 8708 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 4 of USP Almotriptan Related Compound B RS: Change C15H22N3O2S to: C15H21N3O2S AND Line 2 of USP Almotriptan Related Compound D RS: Change 1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl… Read More |
DESLORATADINE TABLETS | IMPURITIES | USP41–NF36 | 1178 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Organic Impurities: Add Protect all solutions containing desloratadine from light. |
DOXEPIN HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 1404 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Doxepin Related Compound C RS: Change (E,Z)-3-(Dibenzo[b,e]oxepin-11(6H-ylidene)-N-methyl-propoan-1-amine. to: (E,Z)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-… Read More |
TRANYLCYPROMINE TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP41–NF36 | Online | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | This erratum applies to the new USP-NF ONLINE platform only. Change System suitability ▲▲1S (USP41) Sample: Standard solution Suitability requirements Tailing factor… Read More |
ECHINACEA PURPUREA ROOT | IDENTIFICATION | USP40–NF35 | 6940 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF… Read More |
FISH OIL CONTAINING OMEGA-3 ACIDS CAPSULES | DEFINITION | USP41–NF36 | 4620 | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 6: Change Scombroidae, to: Scombridae, |
POWDERED VALERIAN EXTRACT | IDENTIFICATION/A. Thin-Layer Chromatography | USP40–NF35 | 7241 | 29-Dec-2017 | 1-Jan-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of Chromatographic system/Developing solvent system:Change acetic acid to: glacial acetic acid AND Line 2 ofChromatographic system/Derivatization reagent B: Change aceticacid to: glacial acetic acid |
<210> MONOSACCHARIDE ANALYSIS | PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids | First Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 6 of Analysis: Change Convert the protein concentration from mg/mL to (1 μM = 1 nmol/mL). to: Convert the protein concentration from mg/mL to μM (1 μM = 1 nmol/mL). |
LEVODOPA | IMPURITIES/Organic Impurities | USP41–NF36 | 2392 | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Footnote a of Table 1: Change 3-(3,4,6-Trihydroxyphenyl)alanine. to: 3-(3,4,6-Trihydroxyphenyl)alanine; also known as 3-(2,4,5-Trihydroxyphenyl)-L-alanine. |
TIMOLOL MALEATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP40–NF35 | 8416 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Timolol Related Compound A RS: Change (R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol. C13H24N4O3S 316.42 to: (R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,… Read More |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS | USP41–NF36 | 6403 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Plastic Additives/Reference solutions/Reference solution I: Change 0.24 mg/mL of USP Plastic Additive 4 RS prepared in the Solvent mixture to: 0.24 mg/mL of USP Plastic Additive 4 RS prepared in methylene… Read More |
PURE STEAM | ADDITIONAL REQUIREMENTS | USP41–NF36 | 4348 | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Delete • USP Reference Standards <11> USP 1,4-Benzoquinone RS |
HYDROXYZINE HYDROCHLORIDE TABLETS | ASSAY/Procedure | USP40–NF35 | 4542 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2of Solution B: Change (0.5: 99.5) to: (0.05: 99.95) |
AMLODIPINE AND ATORVASTATIN TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP41–NF36 | 8270 | 23-Feb-2018 | 1-Mar-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In the variable definition list of the second equation in Analysis: Change Mr2 = molecular weight of atorvastatin calcium, 1209.39 to: Mr2 = molecular weight of atorvastatin calcium, 1155.34 |
ZONISAMIDE CAPSULES | PERFORMANCE TESTS/Dissolution <711> | USP41–NF36 | 4410 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Apparatus 2: Change 75 rpm, with sinkers (see Dissolution <711>, Figure 2a) to: 75 rpm. Use suitable sinkers, if necessary. |
<121> INSULIN ASSAYS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP41–NF36 | 6054 | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | This erratum applies to the new USP-NF ONLINE platform only. Delete USP Insulin RS |