Monograph Title Sort descending | Section | Source Publication | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
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<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. |
<381> ELASTOMERIC CLOSURES FOR INJECTIONS | PHYSICOCHEMICAL TESTS/Heavy Metals | Revision Bulletin (Official January 01, 2018) | Online | 31-Aug-2018 | 1-Sep-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Change Test preparation: Into a 50-mL color-comparison tube place 10.0 mL of Solution S. to: Test preparation: Into a 50-mL color-comparison tube pipet 10.0 mL of Solution S and dilute with water to 25 mL. Using a pH meter or… Read More |
<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 |
<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS | SPECIFIC TESTS FOR TDS | USPNF Online | Online | 28-Jul-2023 | 1-Dec-2023 | NA | NA | In Release Liner Peel Test: Change The product fails the test if the mean peel force is outside the acceptable range determined during product development. to: The product fails the test if the overall mean peel force is outside the acceptable range… Read More |
<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 |
<430> PARTICLE SIZE ANALYSIS BY DYNAMIC LIGHT SCATTERING | GLOSSARY | USPNF Online | Online | 27-Oct-2023 | 1-May-2024 | NA | NA | In Average particle diameter: Change expressed in nanometers. to: expressed in meters. AND In Viscosity: Change in millipascal-seconds (mPa・s). to: in pascal-seconds (Pa・s). |
<466> ORDINARY IMPURITIES | KEY FOR VISUALIZATION TECHNIQUES | 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 3. Solution A–Mix 850 mg of bismuth subnitrate with 40 mL of water and 10 mL of glacial acetic acid. 4. Solution B–Dissolve 8 g of potassium iodide in 20 mL of water.… 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 |
<467> RESIDUAL SOLVENTS | USP REFERENCE STANDARDS <11> | USPNF Online | Online | 26-Aug-2022 | 1-Sep-2022 | NA | NA | Change USP Residual Solvent Class 2—Mixture C RS to: USP Residual Solvents Class 2—Mixture C RS |
<481> RIBOFLAVIN ASSAY | ASSAY | USP40–NF35 | 386 | 31-Mar-2017 | 1-Apr-2017 | USP41–NF36 | USP41–NF36 | Line 2 of the variable definition list in Chemical Methods, Procedure 1/Analysis: Change sodium hydrofluorite to: sodium hydrosulfite |
<4> MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS | PRODUCT QUALITY TESTS FOR MUCOSAL DRUG PRODUCTS/General Necessary Tests/Impurities | USP38–NF33 | 76 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 1 of footnote 2: Change http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2_Guideline.pdf. to: … Read More |
<551> VITAMIN E ASSAY | ASSAY/Procedure 4/Chromatographic system | First Supplement to USP37–NF32 | 6338 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Flow rate: Change 1.5 mL/min to: 1 mL/min |
<55> BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS | D-VALUE DETERMINATION | USP42–NF37 | 6385 | 25-Oct-2019 | 1-Nov-2019 | NA | NA | In the third paragraph in Procedure: Change stated spore filter to: stated spore titer |
<561> ARTICLES OF BOTANICAL ORIGIN | TEST FOR AFLATOXINS/Method I | USP42–NF37 | 6701 | 31-May-2019 | 1-Jun-2019 | NA | NA | In Aflatoxin standard solution: Change ε = molecular absorptivity to: ε = molar absorptivity AND in paragraph 2 of Aflatoxin standard solution: Change transfer an accurate volume of each aflatoxin standard stock solution to:… Read More |
<561> ARTICLES OF BOTANICAL ORIGIN | PESTICIDE RESIDUE ANALYSIS/Limits | USPNF2021 Issue 1 | Online | 29-Oct-2021 | 1-Nov-2021 | NA | NA | In Qualitative and Quantitative Analysis of Pesticide Residues: Change [Note—Current version Document No. SANTE/11813/2017, https://ec.europa.eu/food/… Read More |
<565> BOTANICAL EXTRACTS | PREPARATIONS | USPNF Online | Online | 27-May-2022 | 1-Jun-2022 | NA | NA | In General Pharmacopeial Requirements/Pesticide Residues: Change where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)… Read More |
<581> VITAMIN D ASSAY | ASSAY/Chromatographic Methods | USP43–NF38 | 6808 | 28-Aug-2020 | 1-Sep-2020 | NA | NA | In the second Calculate statement in Procedure 7/Analysis/Precholecalciferol and pre-ergocalciferol response factor: Change pre-ergolecalciferol to: pre-ergocalciferol |
<581> VITAMIN D ASSAY | ASSAY/Procedure 8 | First Supplement to USP41–NF36 | Online | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Aqueous potassium hydroxide solution: Change 800 mg to: 800 g |
<581> VITAMIN D ASSAY | ASSAY/Chromatographic Methods/Procedure 8 | USP40–NF35 | 462 | 28-Jul-2017 | 1-Aug-2017 | USP42–NF37 | First Supplement to USP41–NF36 | Clean-up chromatographic system: Add Flow rate: 1.1 mL/min AND Analytical chromatographic system: Add Flow rate: 1.0 mL/min |
<601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS | C. AERODYNAMIC SIZE DISTRIBUTION—INHALATION AEROSOLS, SPRAYS, AND POWDERS | USP41–NF36 | 6327 | 23-Feb-2018 | 1-Mar-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Figure 6: Change Boquilla del Inhalador to: Inhaler Mouthpiece AND Change Tubo de Admisión to: Induction Port AND Change Cono de Ingreso to: Entrance Cone |
<601> INHALATION AND NASAL DRUG PRODUCTS—AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS | C. AERODYNAMIC SIZE DISTRIBUTION—INHALATION AEROSOLS, SPRAYS, AND POWDERS | USP38–NF33 | 388 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders—Marple Miller Impactor/C.3.1 Design—Apparatus 2: Change Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during… Read More |
<603> TOPICAL AEROSOLS | DELIVERED-DOSE UNIFORMITY | USP40–NF35 | 499 | 26-May-2017 | 1-Jun-2017 | USP41–NF36 | USP41–NF36 | Line 2: Change proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>, to: proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality… Read More |
<621> CHROMATOGRAPHY | SYSTEM SUITABILITY/Stationary Phase | USP35–NF30 | 258 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Line 3 of Flow Rate (HPLC): Change … Read More |
<621> CHROMATOGRAPHY | ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS | USPNF Online | Online | 29-Apr-2022 | 1-Dec-2022 | NA | NA | In Liquid Chromatography: Isocratic Elution/Injection volume: Change Result = (Vinj2 = Vinj1 (L2 dc22 )/(L1… Read More |
<621> CHROMATOGRAPHY | ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS | USPNF Online | Online | 26-Aug-2022 | 1-Dec-2022 | NA | NA | In Liquid Chromatography: Isocratic Elution/Injection volume: Change L2 = internal diameter of the column used (mm) dc1 = particle size indicated in the monograph (µm) dc2 =… Read More |
<621> CHROMATOGRAPHY | SYSTEM SUITABILITY | USPNF Online | Online | 25-Mar-2022 | 1-Dec-2022 | NA | NA | Change System Repeatability—Assay of an Active Substance or an Excipient to: System Repeatability |
<631> COLOR AND ACHROMICITY | METHOD II: INSTRUMENTAL (QUANTITATIVE) ASSESSMENT OF COLOR AND COLOR MATCHES | USPNF Online | Online | 17-Nov-2023 | 1-Dec-2023 | NA | NA | In Table 5: Change Sum 98.809 100.000 107.307 White point 98.811 100.000 107.304 to: Sum 94.809 100.000 107.307 White point 94.811 100.000 107.304 |
<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) |
<659> PACKAGING AND STORAGE REQUIREMENTS | GENERAL DEFINITIONS | USP37–NF32 | 315 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-… Read More |
<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 |
<659> PACKAGING AND STORAGE REQUIREMENTS | GENERAL DEFINITIONS | USP38–NF33 | 447 | 20-Nov-2015 | 1-Dec-2015 | USP40–NF35 | Second Supplement to USP39–NF34 | Line 1 of Single-Dose (see also Injections <1>, Containers for Injections): Change A single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-… 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 |
<660> Containers—Glass | SPECIFIC TESTS/Hydrolytic Resistance/Method | First Supplement to USP35–NF30 | 5150 | 30-Nov-2012 | 1-Dec-2012 | USP37–NF32 | Second Supplement to USP36–NF31 | In the Note in line 11 of Titration: Change Rinse the grains by swirling with three 15-mL portions of Purified Water, and add the washings to the main solution. to: Rinse the grains by swirling with three 15-mL portions of Carbon Dioxide-Free Water, and add the washings to the main… Read More |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS | USP40–NF35 | 542 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change 1.0 mg/mL of bromophenol blue, to: 1.0 mg/mL of bromothymol blue, AND Line 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic… Read More |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS/Physicochemical Tests/Absorbance | USP39–NF34 | 493 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Line 3 of Plasticized polyvinyl chloride: Delete Additionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6. |
<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 |
<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 |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | SPECIFICATIONS/Polyethylene/Extractable Metals | USP39–NF34 | 493 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Line 1 of Zirconium: Change 1 µg/g. to: 0.1 µg/g. |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | SPECIFICATIONS/Polyethylene Terephthalate and Polyethylene Terephthalate G/Extractable Metals | USP39–NF34 | 493 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Line 1 of Titanium: Change 0.1 µg/g. to: 1 µg/g. |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS/Tin in Non-Tin-Stabilized Materials | USP41–NF36 | 6403 | 30-Mar-2018 | 1-Apr-2018 | USP42–NF37 | USP42–NF37 | Line 3 of Sample solution: Change If the solution is not colorless, add the sodium sulfate to: If the solution is not colorless, add the sodium sulfite |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS/Extractions/Table 3 | USP39–NF34 | 493 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Column 4 of S3 row: Change Extractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Zn to: Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn |
<661.1> PLASTIC MATERIALS OF CONSTRUCTION | TEST METHODS/Extractions/Table 3 | USP39–NF34 | 493 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Line 1 of footnote b: Change For nonplasticized polyethylene only. to: For polyethylene only. |
<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 |
<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE | TEST METHODS/Physicochemical Tests/Water Extraction/Acidity or alkalinity | USP39–NF34 | 506 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 2 of Methyl red TS 2: Change NMT 0.1 mL of 0.02 N hydrochloric acid to: NMT 0.1 mL of 0.02 N sodium hydroxide |
<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 |
<670> AUXILIARY PACKAGING COMPONENTS | DESICCANTS/Silica Gel/Inorganic Impurities | USP39–NF34 | 510 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 1 of Soluble ionizable salts: Change (as NaSO3): to: (as Na2SO4): |
<671> CONTAINERS--PERFORMANCE TESTING | MOISTURE VAPOR TRANSMISSION/Packaging System Classification for Multiple-Unit Containers and Unit-Dose Containers for Liquid Oral Dosage Forms/Procedure | USP38–NF33 | 465 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Line 1 of the Equation: Change [(W1i − WT) − (W14i − WT) − (WC1 − WC14)] × 365 × {[100/(W1i − WT)] × 14} to: [(W1i − W… Read More |
<698> DELIVERABLE VOLUME | ACCEPTANCE CRITERIA/For Multiple-Unit Containers | First Supplement to USP35–NF30 | 5154 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Figure 1, right branch, left box: Change
Volume of 1 more containers is less than 95% LV to: Volume of 1 or more containers is less than 95% LV |
<711> DISSOLUTION | INTERPRETATION/Immediate-Release Dosage Forms/Immediate-Release Dosage Forms Pooled Sample | USP39–NF34 | 540 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Row 3 of Column 1 of Acceptance Table for a Pooled Sample: Change S1 to: S2 AND Row 4 of Column 1 of Acceptance Table for a Pooled Sample: Change S1 to: S3 |