Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
RILUZOLE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 3882 | 26-Mar-2021 | 1-Apr-2021 | NA | NA | In USP Riluzole Related Compound A RS: Change 4-Trifluoromethoxyphenylamine; 4-trifluoromethoxyanaline. C7H6F3NO 177.12 to: 4-(Trifluoromethoxy)aniline. C7H6F3NO 177.… Read More |
MIRTAZAPINE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | Online | 26-Mar-2021 | 1-Apr-2021 | NA | NA | In USP Mirtazapine Resolution Mixture RS: Change Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine. to: Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt… Read More |
<659> PACKAGING AND STORAGE REQUIREMENTS | GENERAL DEFINITIONS/Packaging Definitions | Second Supplement to USP43–NF38 | Online | 26-Mar-2021 | 1-Apr-2021 | NA | NA | In Light-resistant container: Change 〈671〉, Spectral Transmission to: 〈671〉, Spectral Transmission for Light-Resistant Packaging Components or Systems |
NADOLOL AND BENDROFLUMETHIAZIDE TABLETS | IMPURITIES | USPNF 2021 ISSUE 1 | Online | 26-Mar-2021 | 1-May-2021 | NA | NA | In Organic Impurities, Procedure 2: Bendroflumethiazide Related Impurities/Acceptance criteria: Change The reporting threshold is NMT 0.05%. to: The reporting threshold is 0.05%. |
ZILEUTON | USP Reference standards <11> | USP43–NF38 | 4679 | 26-Mar-2021 | 1-Apr-2021 | NA | NA | In USP Zileuton Related Compound A RS: Change N-(1-Benzo-[b]thien-2-ylethyl)urea. C11H12N2OS 220.30 to: N-(1-Benzo-[b]thien-2-ylethyl)urea; Also known as 1-[1-(Benzo… Read More |
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | Online | 26-Feb-2021 | 1-Mar-2021 | NA | NA | In USP Amlodipine Related Compound A RS: Change 522.93 to: 522.94 |
STRONTIUM CHLORIDE Sr 89 INJECTION | CHEMICAL INFORMATION | USP43–NF38 | 4126 | 26-Feb-2021 | 1-Mar-2021 | NA | NA | Change 89SrC12 to: 89SrCl2 |
FENTANYL CITRATE | CHEMICAL INFORMATION | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | Change 528.59 to: 528.60 |
PACLITAXEL INJECTION | TITLE | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | Change Paclit 1axel Injection to: Paclitaxel Injection |
<643> TOTAL ORGANIC CARBON | PROCEDURES/2. Sterile Water | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | In Column 2 in Table 2: Change 1,4-Benzoquinone (mL/L) to: 1,4-Benzoquinone (mg/L) AND In Column 2 and 4 in Table 3: Change Sucrose Concentration (mg/mL) to: Sucrose Concentration (mg/L) |
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 |
AMITRIPTYLINE HYDROCHLORIDE | ASSAY/Procedure | USP43–NF38 | 261 | 26-Feb-2021 | 1-Mar-2021 | NA | NA | In System suitability solution: Change 0.5 µg/mL of USP Amitriptyline Related Compound A RS, 1 µg/mL of USP Amitriptyline Hydrochloride RS, and 1.5 µg/mL each of USP Amitriptyline Related Compound B RS, USP Cyclobenzaprine Hydrochloride RS, and USP… Read More |
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711> | USP43–NF38 | 4598 | 26-Feb-2021 | 1-Mar-2021 | NA | NA | In Test 2/Analysis: Change Resulti = (rU/rS) × CS × (Mr1/Mr2) to: Resulti = (AU/AS… Read More |
FENTANYL CITRATE | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | In both variable definition lists in Analysis: Change Mr1 = molecular weight of fentanyl citrate, 528.59 Mr2 = molecular weight of fentanyl, 336.47 to: Mr1 = molecular… Read More |
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS | IMPURITIES/Organic Impurities | USP43–NF38 | Online | 26-Feb-2021 | 1-Mar-2021 | NA | NA | In the first variable definition list in Analysis: Change 522.93 to: 522.94 |
CLONIDINE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 1100 | 26-Feb-2021 | 1-Mar-2021 | NA | NA | In USP Clonidine Related Compound A RS: Change 1-Acetyl-2-(2,6-dichlorophenylamino)-2-(4,5-dihydroimidazol). to: 1-Acetyl-2-(2,6-dichlorophenylimino)imidazolidine. |
CLOZAPINE | IMPURITIES/Organic Impurities | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | In System suitability/Suitability requirements/Resolution: Change NLT 2.5 between demethyl clozapine and clozapine to: NLT 2.5 between demethyl clozapine and clozapine, System suitability solution |
<1051> CLEANING GLASS APPARATUS | CLEANING VALIDATION BEST PRACTICES | USPNF 2021 ISSUE 1 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | Change Quantitative Assessment of Cleaning Procedure to: Quantitative Assessment of Cleaning Process |
<1430.6> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—PARTICLE COUNTING VIA LIGHT SCATTERING | 4. FACTORS THAT AFFECT THE TESTING | Second Supplement to USP43–NF38 | Online | 26-Feb-2021 | 1-May-2021 | NA | NA | In paragraph 1: Change an airborne liquid counter. to: an airborne counter. |
FEXOFENADINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 1869 | 29-Jan-2021 | 1-Feb-2021 | NA | NA | In USP Fexofenadine Related Compound B RS: Change 3-[1-Hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl benzeneacetic acid hydrochloride. C32H39NO4 · HCl 538.12 to: 3-[1-Hydroxy-4-[4-(… Read More |
HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION | IMPURITIES/Organic Impurities | USP43–NF38 | 2252 | 29-Jan-2021 | 1-Feb-2021 | NA | NA | In footnote g of Table 3: Change 2,2′-Bihydromorphone. to: (5α)-3-Hydroxy-2-[(5α)-3-hydroxy-17-methyl-6-oxo-4,5-epoxymorphinan-2-yl]-17-methyl-4,5-epoxymorphinan-6-one dihydrochloride. |
<1079> RISKS AND MITIGATION STRATEGIES FOR THE STORAGE AND TRANSPORTATION OF FINISHED DRUG PRODUCTS | 4. RISK MITIGATION CATEGORIES AS QMS ELEMENTS | Second Supplement to USP43–NF38 | Online | 29-Jan-2021 | 1-Feb-2021 | NA | NA | In 4.1 Documentation and Procedures/4.1.3 Labels: Change The use of symbols that are recognized by international organizations is strongly recommended. to: The use of symbols that are recognized by international organizations is strongly… Read More |
DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION | Limit of 5-hydroxymethylfurfural and related substances | USP43–NF38 | 1495 | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Cation-exchange column: Change Proceed as directed under Column Partition Chromatography (see Chromatography 〈621〉), to: Proceed as directed under Chromatography 〈621〉, General Procedures, Column… Read More |
CARVEDILOL | IMPURITIES/Organic Impurities, Procedure 2 | USP43–NF38 | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Table 3/footnote b: Change 1-(2-(2-Methoxyphenoxy)ethylamino)-3-(6,7,8,9-tetrahydro-5H-carbazol-4-yloxy)propan-2-ol. to: 1-(2-(2-Methoxyphenoxy)ethylamino)-3-(2,3,4,9-tetrahydro-1H-carbazol-5-yloxy)propan-2-ol. |
NOREPINEPHRINE BITARTRATE | IDENTIFICATION/C. Procedure | USP43–NF38 | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Sample solution: Change 0.01 µg/mL to: 0.1 mg/mL |
<382> ELASTOMERIC COMPONENT FUNCTIONAL SUITABILITY IN PARENTERAL PRODUCT PACKAGING/DELIVERY SYSTEMS | 5. NEEDLE AND SPIKE ACCESS FUNCTIONAL SUITABILITY TESTS | Second Supplement to USP43–NF38 | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In paragraph 4 of 5.1 Fragmentation/Cartridge systems/Procedure A: Change graticlule to: graticule |
PINDOLOL TABLETS | ASSAY/Procedure | Second Supplement to USP43–NF38 | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Chromatographic system/Run time: Change NLT 2 times the retention time of the nortriptytine peak to: NLT 2 times the retention time of the nortriptyline peak |
FENTANYL | CHEMICAL INFORMATION | USP43–NF38 | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | Change 336.47 to: 336.48 |
DOBUTAMINE IN DEXTROSE INJECTION | ASSAY/Procedure 1: Dextrose | USP43–NF38 | 1470 | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Analysis: Change Result = [(100 × a) × (l/α)] × (1/CU) × (Mr1/Mr2) × 100 to: Result = [(100 × a)/(l × α)] × (1/CU) × (Mr1… Read More |
CARVEDILOL | ADDITIONAL REQUIREMENTS/USP Reference Standards | USP43–NF38 | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In USP Carvedilol Related Compound A RS: Change 629.74 to: 629.75 AND In USP Carvedilol Related Compound B RS: Change 645.74 to: 645.76 AND In USP Carvedilol Related Compound C RS: Change 496.60 to: 496.61 AND In USP… Read More |
NALOXONE HYDROCHLORIDE INJECTION | IMPURITIES/Limit of 2,2′-Bisnaloxone | Revision Bulletin (Official September 01, 2020) | Online | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Analysis: Change [Note—The relative retention times for naloxone and 2,2′-bisnaloxone (4,5′:4′,5″-diepoxy-3,3′,14,14′-tetrahydroxy-17,17′-bis(prop-2-enyl)-2,2′-bimorphinanyl-6,6′-dione) are 1.0 and 2.8, respectively.] to: [Note—The relative… Read More |
FENTANYL CITRATE INJECTION | Assay | USP43–NF38 | 1849 | 18-Dec-2020 | 1-Jan-2021 | NA | NA | In Procedure: Change (336.48/528.59)CD(rU/rS) in which 336.48 and 528.59 are the molecular weights to: (336.48/528.60)CD(rU/rS) in… Read More |
TRYPSIN | CHEMICAL INFORMATION | Second Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | Change C1012H1555N279O324S14 23,293 (for bovine β-Trypsin) to: C1012H1585N279O324S14 23,293 (for bovine β-Trypsin) |
TIAGABINE HYDROCHLORIDE | ASSAY/Procedure | USP43–NF38 | 4365 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In the Standard solution: Change Transfer suitable volumes of the Standard stock solution and Internal standard solution into a suitable volumetric flask and dilute with Diluent to volume. to: 0.1 mg/mL of USP Tiagabine… Read More |
AMIODARONE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In USP Amiodarone Related Compound H RS: Change 2-Chloro-N,N-diethylethanamine. C6H14ClN 135.64 to: 2-Chloro-N,N-diethylethanamine hydrochloride. C6H14ClN · HCl 172.09 |
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION | 1. PRELIMINARY ASSESSMENT | Second Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In paragraph 4 of 1.4 Choosing an apparatus: Change peak vessels to: apex vessels |
<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 |
ORBIFLOXACIN | Related compounds | USP43–NF38 | 3275 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Procedure: Change 20,000(CS)(ri/rS)(1/F) in which CS is the concentration, in mg per mL, of orbifloxacin in the Standard solution; ri is… 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 |
AMLODIPINE AND ATORVASTATIN TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 265 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In USP Atorvastatin Related Compound H RS: Change 540.62 to: 540.64 |
<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 |
<1467> RESIDUAL SOLVENTS—VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES | VERIFICATION OF COMPENDIAL PROCEDURES | USP43–NF38 | 8404 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Limit Procedures: Procedure A and Procedure B/Verification when solvents likely to be present (LTBP) are not known/Specificity: Change or acetonitrile and cis-dichloroethene to: or methylisobutylketone and cis-dichloroethene |
MIRTAZAPINE TABLETS | ADDITIONAL REQUIREMENTS | USP43–NF38 | 2978 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In USP Reference Standards <11>/USP Mirtazapine Resolution Mixture RS: Change This resolution mixture contains approximately 0.1% w/w each of the following: Impurity A: 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c… Read More |
EFAVIRENZ TABLETS | IMPURITIES/Organic Impurities | USP43–NF38 | 1591 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In the footnotes in Table 2: Change d(S,E)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. e(S,Z)-6-Chloro-4-(pent-3-en-1-ynyl)-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. to: d… Read More |
ATORVASTATIN CALCIUM | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 414 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In USP Atorvastatin Related Compound C RS: Change Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt. to: Calcium (3R,5R… 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 |
FENOPROFEN CALCIUM | CHEMICAL INFORMATION | USP43–NF38 | 1843 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | Change [53746-45-5]; to: [71720-56-4]; |
MEBENDAZOLE ORAL SUSPENSION | Identification | USP43–NF38 | 2744 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | Change Mix a quantity of Oral Suspension, equivalent to about 200 mg of mebendazole, with 20 mL of a mixture of chloroform and 96 percent formic acid (19:1). Proceed as directed for Identification under Mebendazole Tablets, beginning with “Warm the… Read More |
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION | 6. ACCEPTANCE CRITERIA | Second Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Row 1 of Table 5 and Table 6: Align Times with Acceptance Criteria |
ATORVASTATIN CALCIUM TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP43–NF38 | 418 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In USP Atorvastatin Related Compound H RS: Change 540.62 to: 540.64 |