Monograph Title | Section | Source Publication Sort descending | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
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 |
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS | ASSAY/Procedure | Second Supplement to USP40–NF35 | 8752 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2of Mobile phase: Change Adjust with phosphoric acid to a pH of 5.0. to: Adjust with diluted sodium hydroxide or phosphoric acid to a pH of 5.0. |
FLUVOXAMINE MALEATE | ASSAY/Procedure | Second Supplement to USP40–NF35 | 8797 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2of Solution A: Change 1 g/L to: 1.1 g/L |
BUMETANIDE TABLETS | ASSAY/Procedure | Second Supplement to USP41–NF36 | Online | 29-Mar-2019 | 1-Apr-2019 | NA | NA | In Sample solution: Change Nominally 0.05 mg/mL of bumetanide prepared as follows. to: Nominally 125 µg/mL of bumetanide prepared as follows. |
ACETAMINOPHEN ORAL SUSPENSION | ASSAY | Second Supplement to USP41–NF36 | Online | 28-Jun-2019 | 1-Jul-2019 | NA | NA | In the first Procedure: Change 90.0%–110.0%▲(Postponed on 1-Aug-2018) to: 90.0%–110.0%▲(RB 1-Aug-2018) |
ZIPRASIDONE HYDROCHLORIDE | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8992 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | In the second variable definition in Analysis: Change rU = peak response of chloroindolinone or ziprasidone related compound F from the Sample solution to: rU = peak response of chloroindolinone,… Read More |
AMITRIPTYLINE HYDROCHLORIDE TABLETS | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8759 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Analysis: Change rU = peak response of amitriptyline related compound A, amitriptyline related compound B, or nortriptyline hydrochloride from the Sample solution rS = peak response of amitriptyline related… Read More |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS | ASSAY/Procedure/Chromatographic system | Second Supplement to USP41–NF36 | 8781 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Column: Change [Note—Conditioning of the Column with Solution A and Solution B (80:20) to: [Note—Conditioning of the Column with Solution A and Solution B (90:10) |
CARBINOXAMINE MALEATE | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8786 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In Standard stock solution: Change (equivalent to 0.05 mg/mL of USP Carbinoxamine Maleate RS free base) and 0.05 mg/mL each of USP Carbinoxamine Related Compound A RS, USP Carbinoxamine Related Compound B RS, and USP Carbinoxamine Related Compound C RS… Read More |
CARBINOXAMINE MALEATE TABLETS | IMPURITIES/Organic Impurities | Second Supplement to USP41–NF36 | 8788 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In the Standard stock solution: Change USP Carbinoxamine Maleate RS free base) to: carbinoxamine) AND In the Standard solution: Change USP Carbinoxamine Maleate RS free base) to: carbinoxamine) AND In the Analysis… Read More |
ZIPRASIDONE HYDROCHLORIDE | IMPURITIES/Organic Impurities/Analysis | Second Supplement to USP41–NF36 | 8993 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | In the second Calculate statement: Change chloroindolinone and ziprasidone related compound F to: chloroindolinone, ziprasidone related compound F, and any individual unspecified impurity AND In the second variable definition list: Change F… Read More |
FLUDROCORTISONE ACETATE TABLETS | IMPURITIES/Organic Impurities/Table 1 | Second Supplement to USP41–NF36 | 8843 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In footnote a: Change 9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate. to: 9-Fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione. |
ESZOPICLONE | ADDITIONAL REQUIREMENTS/USP Reference Standards | Second Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Eszopiclone Related Compound A RS: [Note—This material may be available in the free base or salt form.] 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide… Read More |
MESNA | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP41–NF36 | 8904 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In USP Mesna Related Compound A RS: Change 2-(Acetylthio)ethane-1-sulfonic acid. C4H8O4S2 184.22 to: 2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride. C4… Read More |
ESZOPICLONE TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards | Second Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 2 of USP Eszopiclone Related Compound A RS: [Note—This material may be available in the free base or salt form.] 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide… Read More |
MESNA TABLETS | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | Second Supplement to USP41–NF36 | 8906 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In USP Mesna Related Compound A RS: Change 2-(Acetylthio)ethane-1-sulfonic acid. C4H8O4S2 184.22 to: 2-(Acetylthio)ethane-1-sulfonic acid, potassium salt, crystal adduct with potassium chloride. C4… Read More |
PRAZOSIN HYDROCHLORIDE COMPOUNDED ORAL SUSPENSION | ASSAY/Procedure | Second Supplement to USP41–NF36 | 8945 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | In the Mobile phase: Change tetramethylammonium hydrochloride to: tetramethylammonium hydroxide |
REAGENTS | Reagent Specifications/7,8-Dihydrofolic Acid | Second Supplement to USP41–NF36 | 9052 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | Change (L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-pteridinyl)methyl]amino]benzoyl]-), to: (L-Glutamic Acid, N-[4-[[(2-Amino-3,4,7,8-tetrahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-), |
AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS | IMPURITIES/Organic Impurities | Second Supplement to USP42–NF37 | 9101 | 22-Nov-2019 | 1-Dec-2019 | NA | NA | In Table 4, Footnote h: Change 0.47, to: 0.45, |
25% TETRABUTYLAMMONIUM HYDROXIDE TS | REAGENTS AND REFERENCE TABLES/Solutions | Second Supplement to USP42–NF37 | 9336 | 22-Nov-2019 | 1-Dec-2019 | NA | NA | Change Transfer about 34.82 g to: Transfer about 77.1 g |
<1227> VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES | VALIDATION OF NEUTRALIZATION METHODS—RECOVERY COMPARISONS | Second Supplement to USP42–NF37 | 9616 | 22-Nov-2019 | 1-Dec-2019 | NA | NA | In paragraph 1 in Recovery on Agar Medium: Change If it is necessary to solubilize the test stample, to: If it is necessary to solubilize the test sample, |
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL | 1. OVERVIEW: GENERAL CHAPTERS BASED ON SCATTERING PHENOMENA | Second Supplement to USP42–NF37 | 9634 | 22-Nov-2019 | 1-Dec-2019 | NA | NA | In Row 6 of Column 4 in Table 1: Change Also properties of condensated phrases to: Also properties of condensated phases |
<1430.5> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—SMALL ANGLE X-RAY SCATTERING AND SMALL ANGLE NEUTRON SCATTERING | 6. EXPERIMENTAL CONSIDERATIONS | Second Supplement to USP42–NF37 | Online | 22-Nov-2019 | 1-Dec-2019 | NA | NA | In 6.2 Resolution/6.2.1 Size resolution: Change qmin < π/dmax π/dmax to: qmin < π/dmax |
<857> ULTRAVIOLET-VISIBLE SPECTROSCOPY | QUALIFICATION OF UV-VIS SPECTROMETERS | Second Supplement to USP42–NF37 | 9570 | 27-Dec-2019 | 1-Jan-2020 | NA | NA | In all instances in Table 4: Change < to: ≤ AND In Control of Photometric Response/Acidic Nicotinic Acid Solutions in 0.1 N Hydrochloric Acid/paragraph 1: Change Using nicotinic acid solutions, the absorbance accuracy… Read More |
MEROPENEM FOR INJECTION | ASSAY/Procedure | Second Supplement to USP42–NF37 | 9216 | 31-Jan-2020 | 1-Feb-2020 | NA | NA | In Mobile phase: Change Solution A to: Buffer |
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 |
<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 |
<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 |
<1671> THE APPLICATION OF MOISTURE VAPOR TRANSMISSION RATES FOR SOLID ORAL DOSAGE FORMS IN PLASTIC PACKAGING SYSTEMS | EQUIVALENCY AND APPLICATION OF MVTR DETERMINATION METHOD | Second Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Application/paragraph 3: Change ≤0.8/day/tablet to: ≤0.8 mg/day/tablet |
<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 |
<1092> THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION | 2. METHOD DEVELOPMENT | Second Supplement to USP43–NF38 | Online | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In paragraph 2 of 2.4 Study Design/2.4.1 Time Points: Change Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution 〈1090〉. to: Assessment of Solid Oral Drug Product Performance and… Read More |
<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. |
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) |
<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 |
<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 |
<659> PACKAGING AND STORAGE REQUIREMENTS | GENERAL DEFINITIONS/Packaging Definitions | Second Supplement to USP43–NF38 | Online | 26-Mar-2021 | 1-Dec-2025 | NA | NA | In Light-resistant container: Change 〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems. to: 〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-… Read More |
ZEIN | IDENTIFICATION/C. SDS-Polyacrylamide Gel Electrophoresis | USP35–NF30 | 2019 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Lines 1 and 2 of the Acceptance criteria: Change
Zein has two major bands: the α band is at 21–25 kDa, and the β band is at 17–18 kDa. to: Zein has two major bands for α-zein at 19–26 kDa. |
METHOTREXATE | IMPURITIES/Organic Impurities/Procedure 1: Related Compounds | USP35–NF30 | 3855 | 29-Mar-2013 | 1-Apr-2013 | USP37–NF32 | USP37–NF32 | Footnote b of Impurity Table 1: Change (S)-2-{4-[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methylamino]-N-methylbenzamido}pentanedioic acid. to: (S)-2-(4-{[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methyl](methyl)amino}benzamido)pentanedioic acid. |
Polysorbate 80 | SPECIFIC TESTS/Fats and Fixed Oils, Peroxide Value <401> | USP35–NF30 | 1920 | 30-Nov-2012 | 1-Dec-2012 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 5 of Analysis: Change 0.01 M sodium thiosulfate to: 0.01 M sodium thiosulfate VS |
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE | Assay | USP35–NF30 | 1822 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 2: Change Hypromellose 2906, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose 2906 throughout. to: Hypromellose, except to substitute Low-Substituted Hydroxypropyl Cellulose for Hypromellose throughout. |
ACETAZOLAMIDE FOR INJECTION | ASSAY | USP35–NF30 | 2063 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 19: Change 25C(AU/AS) to: 250C(AU/AS) |
Polysorbate 80 | SPECIFIC TESTS/Fats and Fixed Oils, Saponification Value <401> | USP35–NF30 | 1920 | 30-Nov-2012 | 1-Dec-2012 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 3 of Analysis: Change 0.5 N alcoholic potassium hydroxide to: 0.5 N alcoholic potassium hydroxide VS Line 6 of Analysis: Change 0.5 N hydrochloric acid to: 0.5 N hydrochloric acid VS |
MYRISTYL ALCOHOL | SPECIFIC TESTS/Fats and Fixed Oils, Hydroxyl Value <401> | USP35–NF30 | 1873 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 7 of Analysis: Change Result = [(VU − VB) × F]/W VU = volume of 1 N sodium hydroxide consumed by the Sample (mL) VB = volume of 1 N sodium hydroxide consumed by the Blank (mL)… Read More |
ADENOSINE | IDENTIFICATION/Infrared Absorption <197M> | USP35–NF30 | 2079 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 1: Delete NMT 0.1% |
AZITHROMYCIN | IMPURITIES/Organic Impurities/Procedure 2 | USP35–NF30 | 2279 | 29-Mar-2013 | 1-Apr-2013 | USP37–NF32 | USP37–NF32 | Line 15 of Analysis: Change CS = concentration of USP Azithromycin RS in the Standard solution (µg/mL) to: CS = concentration of USP Azithromycin RS in the Standard solution (mg/mL) AND Add after CU: P = potency of USP… Read More |
Aminosalicylate Sodium | Limit of m-aminophenol | USP35–NF30 | 2177 | 30-Nov-2012 | 1-Dec-2012 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 1 of Test preparation: Change Use the Assay preparation, prepared as directed in the Assay. to: Transfer about 69 mg of Aminosalicylate Sodium, accurately weighed, to a 100-mL low-actinic volumetric flask, add 50 mL of Mobile phase, and swirl to dissolve.… Read More |
AMANTADINE HYDROCHLORIDE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Test 2 | USP35–NF30 | 2153 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 5 of Chromatographic system: Change Column: 0.32-mm × 30-cm, 0.25-μm film, phase G1 to: Column: 0.32-mm × 30-m, 0.25-μm film, phase G1 |
ALPRAZOLAM ORALLY-DISINTEGRATING TABLETS | IMPURITIES/Procedure | USP35–NF30 | 2106 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Change the subsection
Buffer and Diluent: Prepare as directed in the Assay. to: Diluent: Prepare as directed in the Assay. Buffer: 6.8 g/L of monobasic potassium phosphate in water. Adjust with phosphoric acid to a pH of 3.0. |
TAPIOCA STARCH | Limit of oxidizing substances | USP35–NF30 | 1987 | 29-Mar-2013 | 1-Apr-2013 | USP37–NF32 | USP37–NF32 | Line 8: Change Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodide color. to: Add 1 mL of starch TS, and titrate with 0.002 N sodium thiosulfate VS to the disappearance of the starch–iodine color. |
Aminosalicylate Sodium Tablets | Limit of m-aminophenol | USP35–NF30 | 2178 | 30-Nov-2012 | 1-Dec-2012 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 1 of Test solution: Change Use the Assay preparation, prepared as directed in the Assay. to: Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 690 mg of aminosalicylate sodium, to a 100-mL… Read More |