Monograph Title Sort descending | Section | Source Publication | Page Number | Errata Post Date | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
0.002 M EDETATE DISODIUM VS | REAGENTS AND REFERENCE TABLES/Solutions | USP43–NF38 | 6240 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change 0.0744 g to: 0.744 g |
0.02 M EDETATE DISODIUM VS | REAGENTS AND REFERENCE TABLES/Solutions | USP43–NF38 | 6240 | 24-Apr-2020 | 1-May-2020 | NA | NA | Change 0.7444 g to: 7.444 g |
0.1 M ZINC SULFATE VS | STANDARDIZATION | USPNF Online | Online | 26-Aug-2022 | 1-Dec-2022 | NA | NA | In Standardization with visual end point: Change M = mL edetate disodium × edetate disodium/mL ZnSO4 to: M = mL edetate disodium × M edetate disodium/mL ZnSO4 AND In Standardization with potentiometric end point… Read More |
0.1 N POTASSIUM HYDROXIDE VS | REAGENTS AND REFERENCE TABLES/Solutions | USP42–NF37 | 6185 | 22-Nov-2019 | 1-Dec-2019 | NA | NA | Change Standardization: Add 2 drops of phenolphthalein TS to 20 mL of 0.1 N potassium hydroxide VS. Titrate with 0.1 N hydrochloric acid VS until a permanent pale-pink color is produced. to: Standardization: Add 2 drops of phenolphthalein TS… Read More |
0.1 N Potassium Permanganate VS | STANDARDIZATION | USPNF Online | Online | 26-Aug-2022 | 1-Sep-2022 | NA | NA | In Standardization with potentiometric endpoint: Change N = g Na2C2O4/mL KMNnO4 solution × 0.06700 to: N = g Na2C2O4/mL KMnO4 solution × 0.06700 |
2,5-DIHYDROXYBENZOIC ACID | REAGENTS AND REFERENCE TABLES/Reagent Specifications | USP42–NF37 | 6097 | 22-Nov-2019 | 1-Dec-2019 | NA | NA | Change [303-07-1]. to: [490-79-9]. |
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 |
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT | APPENDIX C: EXAMPLES OF OUTLIER TESTS FOR ANALYTICAL DATA/Hampel's Rule | USP39–NF34 | 767 | 30-Sep-2016 | 1-Oct-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Row 13 of Column 4 of Table 5. Test Results of Re-Applied Hampel's Rule: Change 0.14 to: 0.15 |
<1010> ANALYTICAL DATA—INTERPRETATION AND TREATMENT | MEASUREMENT PRINCIPLES AND VARIATION | USP42–NF37 | 7129 | 22-Feb-2019 | 1-Mar-2019 | NA | NA | See https://www.uspnf.com/sites/default/files/usp_pdf/EN/february_2019_errata_image1.pdf for correction |
<1024> BOVINE SERUM | APPENDIX 1 | USP38–NF33 | 719 | 25-Sep-2015 | 1-Oct-2015 | USP40–NF35 | First Supplement to USP39–NF34 | Line 2 of bullet 1 of International Regulations and Guidance Documents in second paragraph: Change http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf to: … Read More |
<1042> CELL BANKING PRACTICES FOR RECOMBINANT BIOLOGICS | 5. CELL BANK CHARACTERIZATION | USPNF Online | Online | 31-Mar-2023 | 1-May-2023 | NA | NA | In Table 4: Change In vitro assayd,e + + +f to: In vitro assayd,e + −f + |
<1046> CELL-BASED ADVANCED THERAPIES AND TISSUE-BASED PRODUCTS | REGULATIONS AND STANDARDS | USP43–NF38 | 7400 | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In Table 5/Row 8 of Column 2: Change 221 CFR 1271 to: 21 CFR 1271 |
<1046> CELL-BASED ADVANCED THERAPIES AND TISSUE-BASED PRODUCTS | ANALYTICAL METHODS | USP43–NF38 | 7400 | 30-Oct-2020 | 1-Nov-2020 | NA | NA | In In-Process Controls/paragraph 2: Change Refer to Risk Assessment for discussion on critical process parameters (CPP). to: Refer to Quality Systems for discussion on critical process parameters (CPP). AND In Final… Read More |
<1047> GENE THERAPY PRODUCTS | REGULATIONS AND STANDARDS | USP38–NF33 | 883 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 8: Delete and, in particular, www.fda.gov/cber/publications.htm |
<1047> GENE THERAPY PRODUCTS | APPENDIX | USP38–NF33 | 883 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 8 of National and International Regulatory Documents: Delete (http://www4.od.nih.gov/oba/guidelines.html) |
<1050> VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN | VI. Evaluation and Characterization of Viral Clearance Procedures | USP35–NF30 | 553 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Row 10 (Reovirus 3) of Column 5 (Genome) of Table A-1: Change DNA to: RNA |
<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 |
<1052> BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS | METHODOLOGIES OF AMINO ACID ANALYSIS GENERAL PRINCIPLES | USP36–NF31 | 619 | 31-May-2013 | 1-Jun-2013 | USP37–NF32 | USP37–NF32 | Change the section title Method 6—Postcolumn DABS-CI Derivatization General Principle to: Method 6—Precolumn DABS-CI Derivatization General Principle |
<1052> BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS | APPENDIX | USP36–NF31 | 619 | 31-May-2013 | 1-Jun-2013 | USP37–NF32 | USP37–NF32 | Change the section title Method 6—Postcolumn DABS-CI Derivatization to: Method 6—Precolumn DABS-CI Derivatization |
<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 |
<1058> ANALYTICAL INSTRUMENT QUALIFICATION | ANALYTICAL INSTRUMENT QUALIFICATION PROCESS/Qualification Phases | First Supplement to USP40–NF35 | 8083 | 27-Jan-2017 | 1-Feb-2017 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 2 of paragraph 1 of Operational Qualification: Change OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document. to: OQ demonstrates fitness for the selected use, and should reflect URS. AND Line 2 of paragraph 3 of Operational… Read More |
<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS | QUALITY MANAGEMENT SYSTEM/Storage Management System/Receiving and Transferring Drug Products | USP36–NF31 | 693 | 29-Mar-2013 | 1-Apr-2013 | USP37–NF32 | USP37–NF32 | Line 1 of footnote 1: Change JP Edmond, to: JP Emond, |
<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 |
<1085> GUIDELINES ON THE ENDOTOXINS TEST | METHOD SUITABILITY | USP43–NF38 | 7665 | 20-Nov-2020 | 1-Dec-2020 | NA | NA | In Row 2 of Column 3 of Table 3: Change hydrochloride to: hydrochloric acid AND In paragraph 2 of Method Suitability Testing/Common Test Interferences: Change hydrochloride to: hydrochloric acid |
<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 |
<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 |
<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 |
<1103> IMMUNOLOGICAL TEST METHODS—ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) | PROCEDURES/Solid Phase | USP40–NF35 | 1344 | 26-Jan-2018 | 1-Feb-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 7 of Coating the Solid Phase—Immobilization of Capture Reagent: Change 1–10 µg/well to: 1–10 µg/mL |
<111> DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS | COMBINATION OF INDEPENDENT ASSAYS/Method 2 | USP43–NF38 | 6543 | 31-Jul-2020 | 1-Aug-2020 | NA | NA | In the second bullet in Alternate weights for inter-assay component of variation: Delete the duplicate equation |
<1125> NUCLEIC ACID-BASED TECHNIQUES -- GENERAL | APPENDICES | USP43–NF38 | 7865 | 24-Apr-2020 | 1-May-2020 | NA | NA | In Appendix 2: Delete the Row for dNTP dinucleotide triphosphate |
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL | APPENDICES/Appendix 1: Regulations and Standards | USP40–NF35 | 1471 | 26-May-2017 | 1-Jun-2017 | USP41–NF36 | USP41–NF36 | Line 1 of bullet 1: Change "Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms" (1993) to: "Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens" (2005) |
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL | APPENDICES/Appendix 1 | USP43–NF38 | 7865 | 31-Jul-2020 | 1-Aug-2020 | NA | NA | In footnote 1: Change http://ts.nist.gov/measurementservices/referencematerials/index.cfm. to: https://www.nist.gov/srm. |
<1132> RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS | 4. HCP IMMUNOASSAY METHOD VALIDATION/4.3 Sample Linearity/Table 4 | Second Supplement to USP38–NF33 | 7647 | 25-Mar-2016 | 1-Apr-2016 | USP40–NF35 | USP40–NF35 | Product column: Change 10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16 to: 10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625 AND Sample 1/HCP ratio column: Change 4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6 to: 4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6 AND… Read More |
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE | 10. ALLIGATION ALTERNATE AND ALGEBRA METHODS FOR COMBINING MULTIPLE STRENGTHS OF THE SAME ACTIVE PHARMACEUTICAL INGREDIENT | USP42–NF37 | 7831 | 26-Apr-2019 | 1-May-2019 | NA | NA | In 10.2 Algebra Method/10.2.1 Calculating by using the algebra method/Examples—Algebra method: In example 2, in equations 1, 2, 3, and 4 in all instances: Change Cs to: Qs AND In example… Read More |
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE | 19. MEAN KINETIC TEMPERATURE | USP42–NF37 | 7831 | 30-Aug-2019 | 1-Sep-2019 | NA | NA | In 19.4 Example Calculations of MKT for CRT Storage Evaluation/Example 3—Calculation of Annual MKTStep 3: Change 3.354 to: 3.340 AND In Step 4: Change 2.795 to: 2.783 AND In Step 5:… Read More |
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE | 19. MEAN KINETIC TEMPERATURE/19.2 MKT Equation | USP42–NF37 | 7831 | 26-Apr-2019 | 1-May-2019 | NA | NA | In the variable definition list: Change Tn = value for the total number of storage temperatures recorded during the observation period temperature recorded during the nth time period, e.g., nth week to: Tn… Read More |
<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS | SECTION 2: QUALITY, ORGANIZATION, AND DOCUMENTATION/2.8 Contract Activities | USP38–NF33 | 1396 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Footnote 2: Change http://whqlibdoc.who.int/trs/WHO_TRS_917_annex2.pdf (Accessed June 30, 2011) to: … Read More |
<1197> GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS | SECTION 4: RETURNED GOODS, DISPATCH, TRANSPORT, IMPORTATION, ADULTERATION, AND TRACEABILITY/4.7 Importation | USP38–NF33 | 1396 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Footnote 11: Delete http://www.fda.gov/ForIndustry/ImportProgram/AdmissibilityDeterminationsforShipmentsofForeign-originOASIS/ucm077691.htm (Accessed June 6,… Read More |
<1207> STERILE PRODUCT PACKAGING−INTEGRITY EVALUATION | 5. PRODUCT–PACKAGE QUALITY REQUIREMENTS AND THE MAXIMUM ALLOWABLE LEAKAGE LIMIT/5.1 Sterility and Product Formulation Content must be Preserved; Gas Headspace Content Preservation is not Required | First Supplement to USP39–NF34 | 7764 | 18-Nov-2016 | 1-Dec-2016 | USP41–NF36 | Second Supplement to USP40–NF35 | Line 3 of paragraph 5: Change ultra-cold storage (<80°) to: ultra-cold storage (≤−80°) |
<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)% |
<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION | 3. ACCURACY AND PRECISION | USP41–NF36 | 7622 | 27-Apr-2018 | 1-May-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 4 of paragraph 3 of 3.2 Combined Validation of Accuracy and Precision: Change validate evaluate to: validate AND Variable definition in paragraph 6 of 3.2 Combined Validation of Accuracy and Precision:… Read More |
<121> INSULIN ASSAYS | ASSAY/Rabbit Blood Sugar Method—Quantitative | Revision Bulletin (Official May 01, 2019) | Online | 27-Dec-2019 | 1-Jan-2020 | NA | NA | In Standard stock solution: Change of USP Insulin RS of the appropriate species to: of the USP Insulin Reference Standard of the appropriate species AND In Sample stock solution: Change of USP Insulin RS of the appropriate species.… Read More |
<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 |
<1222> TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE | INTRODUCTION | USP42–NF37 | 8021 | 25-Oct-2019 | 1-Nov-2019 | NA | NA | In paragraphs 4 and 5: Change a probability of a PNSU to: a PNSU |
<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, |
<1228.1> DRY HEAT DEPYROGENATION | INTRODUCTION | USPNF Online | Online | 23-Feb-2024 | 1-Mar-2024 | NA | NA | Change parental manufacturing to: parenteral manufacturing |
<1228.4> DEPYROGENATION BY RINSING | ROUTINE PROCESS CONTROL | USP42–NF37 | 8067 | 25-Oct-2019 | 1-Nov-2019 | NA | NA | In the first paragraph: Change WFI to: Water for Injection |
<1229.2> STEAM STERILIZATION OF AQUEOUS LIQUIDS | BIOBURDEN/BIOLOGICAL INDICATOR METHOD/Routine Process Control | USP42–NF37 | 8082 | 25-Oct-2019 | 1-Nov-2019 | NA | NA | In the first paragraph: Change calibrartion to: calibration |
<123> GLUCAGON BIOIDENTITY TESTS | PROCEDURE/B. In Vitro Cell-Based Bioidentity Test | First Supplement to USP41–NF36 | 8627 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 1 of Medium B: Change Kreb's salt solution containing 0.3% (v/v) human serum albumen to: Krebs' salt solution containing 0.3% (v/v) human serum albumin AND Line 1 of Medium C: change Kreb's salt solution containing 0.3% (v/v)… Read More |
<123> GLUCAGON BIOIDENTITY TESTS | PROCEDURE/B. In Vitro Cell-Based Bioidentity Test | USP42–NF37 | 6478 | 26-Jul-2019 | 1-Aug-2019 | NA | NA | In Standard stock solution: Change 0.4 µg/mL to: 4 µg/mL |