Monograph Title | Section | Source Publication Sort descending | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
CALCIUM CITRATE MALATE | IMPURITIES/Limit of Fluoride | First Supplement to USP41–NF36 | 8299 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of Standard solution: Change Transfer 1.0 mL of Standard stock solution to: Transfer 2.0 mL of Standard stock solution |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | ASSAY/Procedure/Chromatographic system | First Supplement to USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Column: Change 4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B ▲(90:10)▲ (ERR 1-Mar-2019) for about 30 min is recommended prior to use.] to: 4.6-mm × 15-cm… Read More |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP42–NF37 | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Row 2 of Column 3 of Table 4: Change 0.014▲/0.028▲2S (USP41) to: 0.014 AND In Row 3 of Column 3 of Table 4: Change 0.014 to: 0.014/0.028 AND In Chromatographic… Read More |
BENAZEPRIL HYDROCHLORIDE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 1 | First Supplement to USP42–NF37 | 8644 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In the Standard solution: Change µg/mL to: µg/µL |
EPHEDRINE HYDROCHLORIDE | CHEMICAL INFORMATION | First Supplement to USP42–NF37 | 8682 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | Add (1R,2S)-2-(Methylamino)-1-phenylpropan-1-ol hydrochloride; |
PAROXETINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP42–NF37 | 8788 | 27-Sep-2019 | 1-Oct-2019 | NA | NA | In USP Paroxetine Related Compound G RS: Change 405.46 to: 441.92 |
LAMOTRIGINE TABLETS FOR ORAL SUSPENSION | PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure 1 | First Supplement to USP42–NF37 | 8720 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Buffer: Change glacial acetic acid acid to: glacial acetic acid |
LOVASTATIN TABLETS | PERFORMANCE TESTS/Dissolution <711> | First Supplement to USP42–NF37 | 8727 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Mobile phase: Change Processed as directed in the Assay to: Proceed as directed in the Assay. |
OXALIPLATIN INJECTION | IMPURITIES/Limit of Oxalic Acid/Chromatographic system | First Supplement to USP42–NF37 | 8781 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Column: Change L31 to: L81 |
TIAGABINE HYDROCHLORIDE | ASSAY/Procedure | First Supplement to USP42–NF37 | 8823 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Analysis: Change Result = (RU/RS) × (CS/CU) × ▲(Mr1/Mr2) ×▲ (USP 1-Aug-2019) 100 to: … Read More |
TIAGABINE HYDROCHLORIDE | IMPURITIES/Limit of (S)-(+) Isomer/Mobile phase | First Supplement to USP42–NF37 | 8823 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | Change Hexane, to: n-Hexane, AND Change hexane to: n-hexane |
<41> BALANCES | REPEATABILITY | First Supplement to USP42–NF37 | 9011 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In all instances in paragraph 2: Change sr to: s AND In paragraph 2: Change is found to be 0.0015, then Mmin must be ≥ 0.3000 g or 300 mg. to: is found to be 0.00015, then Mmin… Read More |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS | ASSAY/Procedure | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In Buffer A: Change monobasic potassium phosphate to: monobasic sodium phosphate |
METHYLENE BLUE | CHEMICAL INFORMATION | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | Change Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, chloride; 3,7-Bis(dimethylamino)phenothiazin-5-ium chloride; to: Phenothiazin‐5‐ium, 3,7‐bis(dimethylamino)‐, chloride, hydrate (1:1:x); 3,7‐Bis(dimethylamino)phenothiazin‐5‐ium chloride… Read More |
<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE | SCOPE/Table 1 | First Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | Change If light protection is necessaryc to: If light protection is necessary AND Change Row 11 Chemical Suitability for Use Assessment Risk-based testing Risk-based testing to: Chemical Suitability for Use Assessment Risk-… Read More |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | INTRODUCTION | First Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | Delete An example of an extractable elements testing strategy is provided in Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact 〈1661〉. |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | POLYAMIDE 6 | First Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Related Substances/Chromatographic system/Column: Change 0.25-mm × 0.25-µm; phase G25 to: 30-m × 0.25-mm; 0.25-µm phase G25 |
<661> PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION | POLYETHYLENE TEREPHTHALATE BOTTLES AND POLYETHYLENE TEREPHTHALATE G CONTAINERS | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In Heavy Metals, Total Terephthaloyl Moieties, and Ethylene Glycol/Extracting media: Change 50 percent alcohol: Dilute 125 mL of alcohol with water to 238 mL, and mix. 25 percent alcohol: Dilute 125 mL of 50 percent alcohol… Read More |
<31> VOLUMETRIC APPARATUS | STANDARDS OF ACCURACY | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In paragraph 3: Change and then touched against the wall of the receiving vessel to drain the tips. to: and then touched against the wall of the receiving vessel to drain the pipet tip. |
<1661> EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT | 6. APPLICABILITY AND APPLICATION OF <661.1> | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In 6.2 Application/6.2.5 Unaddressed Materials: Change physiochemical to: physicochemical |
ANISE OIL | IDENTIFICATION/A. Chromatographic Identity | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In Acceptance criteria/Chromatographic similarity: Change [Note—The chromatogram of the Standard is similar to the reference chromatogram provided with the lot of being used.] to: [Note—The chromatogram of the Standard is similar… Read More |
CLOMIPHENE CITRATE TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In USP Clomiphene Related Compound A RS: Change (E,Z)-2-[4-(1,2-Diphenylethyl)phenoxy]-N,N-diethylethanamine hydrochloride. to: (E,Z)-2-[4-(1,2-Diphenylethenyl)phenoxy]-N,N-diethylethanamine hydrochloride. |
GALANTAMINE EXTENDED-RELEASE CAPSULES | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP43–NF38 | Online | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In USP Galantamine Hydrobromide Related Compounds Mixture RS: Change Anhydrogalantamine; (4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine. C17H19NO2 to: … Read More |
<1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS | INTRODUCTION | Harmonization (Official December 01, 2015) | Online | 31-Jul-2015 | 1-Aug-2015 | USP40–NF35 | First Supplement to USP39–NF34 | A paragraph before the Introduction was deleted: This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by… Read More |
SODIUM CHLORIDE | IMPURITIES/Limit of Phosphates | Harmonization (Official December 01, 2015) | Online | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 2 of Analysis: Change add 4 mL of sulfomolybdic acid TS, to: add 4 mL of Sulfomolybdic acid solution, |
ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ASSAY/Procedure | Harmonization (Official December 01, 2019) | Online | 29-May-2020 | 1-Jun-2020 | NA | NA | In Analysis: Change M = actual molarity of the Back-titrant (mM/mL) to: M = actual molarity of the Back-titrant (mmol/mL) AND Change F = equivalency factor, 136.06 mg/mM to: F =… Read More |
STEARIC ACID | ASSAY/Procedure/System suitability/Suitability requirements | Harmonization (Official May 01, 2015) | Online | 31-Jul-2015 | 1-Aug-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 3 of Relative standard deviation: Change peaks (from six replicate injections of Sample solution); to: peaks, from six replicate injections; |
HYPROMELLOSE PHTHALATE | IMPURITIES/Chloride and Sulfate <221>, Chloride | Harmonization (Official May 01, 2019) | Online | 26-Apr-2019 | 1-May-2019 | NA | NA | In Analysis: Change ▲Add 1 mL of silver nitrate TS to the Standard solution and then add a 50-mL portion of the Sample solution. Mix and allow to stand for 5 min protected from direct sunlight. Compare the turbidity of the… Read More |
GELATIN | SPECIFIC TESTS/Sulfur Dioxide | Harmonization (Official May 01, 2020) | 5783 | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In three instances in Analysis: Change 0.1 M sodium hydroxide to: Titrant AND In the equation: Change M to: N AND In the variable definition list: Change M = actual molarity of the … Read More |
COPOVIDONE | IMPURITIES/Limit of Monomers (1-Vinyl-2-Pyrrolidone and Vinyl Acetate) | Harmonization (Official May 01, 2021) | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | In Standard solution: Change 0.25 μg/mL of 1-vinyl-2-pyrrolidone and 5 μg/mL of vinyl acetate, respectively, diluted from the Standard stock solution in Mobile phase to: 0.25 μg/mL of 1-vinyl-2-pyrrolidone and 0.25 μg/mL of vinyl… Read More |
<467> RESIDUAL SOLVENTS | APPENDICES/Appendix 3 | Interim Revision Announcement (Official December 01, 2020) | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In the denominator in the equation in the final paragraph: Change at mK−1 to: atm K−1 |
ISOPHANE INSULIN HUMAN SUSPENSION | ASSAY/Procedure | Interim Revision Announcement (Official January 01, 2019) | Online | 29-Mar-2019 | 1-Apr-2019 | NA | NA | In Standard solution: Change USP Insulin Beef RS to: USP Insulin Human RS |
DEXAMETHASONE SODIUM PHOSPHATE INJECTION | ASSAY/Procedure | Interim Revision Announcement (Official May 01, 2015) | Online | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 9 of Analysis: Change CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL) to: CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL) |
DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION | ASSAY/Procedure | Interim Revision Announcement (Official May 01, 2015) | Online | 29-Jan-2016 | 1-Feb-2016 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 9 of Analysis: Change CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL) to: CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL) |
ALMOTRIPTAN MALATE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Interim Revision Announcement (Official May 01, 2017) | Online | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Almotriptan Related Compound D RS: Change 1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide. C17H25N3O3S 351.46 to: 1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N… Read More |
GOSERELIN ACETATE | IMPURITIES/Organic Impurities: Related Compounds | Interim Revision Announcement (Official May 01, 2020) | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Table 1: Change Goserelinare to: Goserelin |
PAROXETINE HYDROCHLORIDE | CHEMICAL INFORMATION | Interim Revision Announcement (Official May 01, 2021) | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | Change (−)-(3S,4R)-4-(p-Fluorophenyl)-3-[(3,4-methylenedioxy)phenoxy]methyl]piperidine hydrochloride; to: (−)-(3S,4R)-4-(p-Fluorophenyl)-3-[[(3,4-methylenedioxy)phenoxy]methyl]piperidine hydrochloride; |
DIGOXIN | IMPURITIES/Related Glycosides/System suitability | Interim Revision Announcement (Official November 01, 2015) | Online | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Line 2: Change Sample: System suitability solution to: Samples: System suitability solution and Standard solution AND Line 2 of Suitability requirements: Change Resolution: NLT 1.5 between the digoxin and lanatoside C peaks Relative… Read More |
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Revision Bulletin (Official April 01, 2014) | Online | 30-Jan-2015 | 1-Feb-2015 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 2 of USP Valsartan Related Compound B RS: Change (S-N-Butyryl-N-([2′-(1H-tetrazole-5-yl)biphen-4-yl]methyl)-valine. to: N-Butyryl-N-{[2′-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-L-valine. |
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS | ASSAY/Procedure | Revision Bulletin (Official April 01, 2017) | Online | 29-Sep-2017 | 1-Oct-2017 | USP42–NF37 | First Supplement to USP41–NF36 | Line 1 of Chromatographic system/Column: Change 10-µm to: 5-µm AND In the variable definition list in Analysis: Change rU = citrate peak area from the Sample solution rS = citrate peak area from… Read More |
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 |
RITONAVIR CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Test 2 | Revision Bulletin (Official April 01, 2018) | Online | 26-Oct-2018 | 1-Nov-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Row 1 of Column 3 of Table 1: Change Tolerances (Q) to: Tolerances AND Row 3 of Column 3 of Table 1: Change NLT 80% to: NLT 80% (Q) |
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 8 | Revision Bulletin (Official April 01, 2018) | Online | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | In the variable definition list in Analysis: Change CS = concentration of oxybutynin chloride in the Standard solution (mg/mL) to: CS = concentration of USP Oxybutynin Chloride RS in the Standard… Read More |
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS | ASSAY/Procedure | Revision Bulletin (Official April 01, 2018) | Online | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | This erratum applies to the Revision Bulletin posted on www.uspnf.com only. In System suitability: Add [Note—The relative retention times for oxybutynin and oxybutynin related compound A are about 1.0 and 1.6,… Read More |
OXYBUTYNIN CHLORIDE EXTENDED-RELEASE TABLETS | IMPURITIES/Organic Impurities | Revision Bulletin (Official April 01, 2018) | Online | 30-Nov-2018 | 1-Dec-2018 | USP43–NF38 | USP42–NF37 | This erratum applies to the Revision Bulletin posted on www.uspnf.com only. In the variable definition list in Analysis: Change CU = nominal concentration of the Sample solution (mg… Read More |
ROSUVASTATIN TABLETS | PERFORMANCE TESTS/Dissolution <711>/Test 3 | Revision Bulletin (Official April 01, 2019) | Online | 31-May-2019 | 1-Jun-2019 | NA | NA | In Medium: Change (dissolve 63.0 of citric acid to: (dissolve 63.0 g of citric acid |
GANODERMA LUCIDUM FRUITING BODY | COMPOSITION/Content of Triterpenoic Acids | Revision Bulletin (Official August 01, 2014) | Online | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 1 of Standard solution A: Change USP Ganoderic Acid RS to: USP Ganoderic Acid A RS AND Line 3 of variable definition list in Analysis: Change rS = peak area of ganoderic acid in Standard solution A to: rS… Read More |
GANODERMA LUCIDUM FRUITING BODY | SPECIFIC TESTS/Botanical Characteristics | Revision Bulletin (Official August 01, 2014) | Online | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 6 of Macroscopic: Change concentrically culcate to: concentrically sulcate |
GANODERMA LUCIDUM FRUITING BODY POWDER | COMPOSITION/Content of Triterpenoic Acids | Revision Bulletin (Official August 01, 2014) | Online | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 1 of Standard solution A: Change USP Ganoderic Acid RS to: USP Ganoderic Acid A RS AND Line 3 of variable definition list in Analysis: Change rS = peak area of ganoderic acid in Standard solution A to: rS… Read More |
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 |