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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<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS | SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating Instructions | USP40–NF35 | 216 | 26-May-2017 | 1-Jun-2017 | USP41–NF36 | USP41–NF36 | Column 4 for Step 6: Add • For counting bead enumeration, proceed to either Step 7 or Step 8 according to the recommendations of the bead manufacturer. |
<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 |
<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. |
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-GENERAL | 2. INTRODUCTION | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In paragraph five: Change Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉1 to: Determination of Zeta Potential by Electrophoretic Light Scattering 〈432〉 AND In footnote 1: Change This… Read More |
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL | 1. OVERVIEW: GENERAL CHAPTERS BASED ON SCATTERING PHENOMENA | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Table 1: Change 〈1430.6〉a to: 〈1430.6〉 AND Change 〈1430.7〉a to: 〈1430.7〉 AND Delete footnote a |
<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 |
<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 |
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS | AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS | USP41–NF36 | 7874 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of paragraph 3: Change general information chapter Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers <601>), to: general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—… Read More |
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS | AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS | USP43–NF38 | 8407 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | Change Apparatus 5 (see general chapter Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests 〈601〉), a cascade impactor, has been calibrated at 15 L/min specifically to meet the recommendation of the CEN Standard… Read More |
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS | AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS | USP43–NF38 | 8407 | 30-Jul-2021 | 1-Aug-2021 | NA | NA | Please see the updated Figure 2 at online.uspnf.com |
<1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS—CHARACTERIZATION TESTS | 1. INTRODUCTION/1.5 Definitions of Key Terms Relating to This Chapter | USP40–NF35 | 1988 | 31-Mar-2017 | 1-Apr-2017 | USP41–NF36 | USP41–NF36 | Bottom right corner of Figure 1:Change VHC mouthpiece to: Spacer mouthpiece |
<1660> CONTAINERS GLASS-EVALUATION OF INNER SURFACE DURABILITY | EVALUATION OF THE INNER SURFACE DURABILITY/Aggressive Screening Conditions | Second Supplement to USP36–NF31 | 6221 | 31-Jan-2014 | 1-Feb-2014 | USP38–NF33 | Second Supplement to USP37–NF32 | Row 1 of Column 3 of Table 4: Change 3% Citric Acid pH 8.0 to: 3% Sodium Citrate pH 8.0 |
<1661> EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT | APPLICABILITY AND APPLICATION OF <661.1> | USP41–NF36 | 7902 | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of Application/4.: Change proscribed to: prescribed AND Line 3 of Description of Polymers Contained in <661.1>/Polyethylenes: Change Low-density polypropylene (LDPE) to: Low-density polyethylene (… Read More |
<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 |
<1663> ASSESSMENT OF EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS | REFERENCES | USP41–NF36 | 7910 | 27-Jul-2018 | 1-Aug-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 2 of reference 7: Delete http://webstore.ansi.org/RecordDetail.aspx?sku=ASTM%20F1980-07(2011)&source=msn&adgroup=astm. Accessed 19 March 2013. |
<1663> EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING SYSTEMS | REFERENCES | USP39–NF34 | 1835 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Delete references 5, 7, 9, and 12. |
<1664.1> ORALLY INHALED AND NASAL DRUG PRODUCTS | REFERENCES | USP39–NF34 | 1862 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Delete reference 3. |
<1664> ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS | REFERENCES | USP39–NF34 | 1850 | 29-Jul-2016 | 1-Aug-2016 | USP41–NF36 | First Supplement to USP40–NF35 | Delete reference 8. |
<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 |
<1724> SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS | IN VITRO PERFORMANCE TESTS | USP39–NF34 | 1869 | 27-May-2016 | 1-Jun-2016 | USP40–NF35 | USP40–NF35 | Line 7 of Application of Drug Release: Change The individual amounts of drug released from R is plotted versus time, to: The individual amounts of drug released from R are plotted versus the square root of time, |
<1788.1> LIGHT OBSCURATION METHOD FOR THE DETERMINATION OF SUBVISIBLE PARTICULATE MATTER | APPENDIX/Particle Count Accuracy Manual Method Test for MWHC Instruments | USPNF 2021 ISSUE 1 | Online | 24-Sep-2021 | 1-Oct-2021 | NA | NA | In Overview: Change The test is also sensitive to size accuracy at 15 μm, since small errors in size will translate into large errors in count at the midpoint of the PS distribution. to: The test is also sensitive to size accuracy at 15 μm, since… Read More |
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS | LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability | USP37–NF32 | 1301 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 26 of Method 1—MWHC Instruments: Change PB is the average particle count obtained from the suspension; to: PS is the average particle count obtained from the suspension; |
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS | LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability | USP37–NF32 | 1301 | 21-Nov-2014 | 1-Dec-2014 | USP39–NF34 | Second Supplement to USP38–NF33 | Line 11 of Method 2—Multichannel Instruments: Change NMT ±10% of stated size. to: NMT ±10% of stated concentration. |
<1790> VISUAL INSPECTION OF INJECTIONS | 4. INSPECTION LIFE-CYCLE/4.2 Prevention of Particulates | First Supplement to USP40–NF35 | 8099 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 5 of paragraph 1 of Robust Design During Development: Change lamellae (46,47) to: lamellae as discussed in Evaluation of the Inner Surface Durability of Glass Containers <1660> and by the FDA (45) AND Line 2 of paragraph 4 of Robust… Read More |
<1790> VISUAL INSPECTION OF INJECTIONS | 2. BACKGROUND/2.2 Patient Risk | First Supplement to USP40–NF35 | 8099 | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 6 of paragraph 3: Change 109 particles/kg to: 109 particles/kg |
<191> IDENTIFICATION TESTS—GENERAL | CHEMICAL IDENTIFICATION TESTS | USP43–NF38 | 6587 | 24-Apr-2020 | 1-Aug-2020 | NA | NA | In Bicarbonate/B.: Change (1:20) to: (1 in 20) AND In Borate/A.: Change (1:50): to: (1 in 50): AND In Calcium/A.: Change (1:20) to: (1 in 20) AND In Carbonate/B.:… Read More |
<191> IDENTIFICATION TESTS—GENERAL | CHEMICAL IDENTIFICATION TESTS/Thiosulfate | Second Supplement to USP40–NF35 | Online | 17-Nov-2017 | 1-Dec-2017 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 1 of A.: Change yellow; with the addition of sulfur dioxide, filter paper moistened with mercurous nitrate TS blackens. to: yellow, and evolve sulfur dioxide, which blackens filter paper moistened with mercurous nitrate TS. |
<197> SPECTROSCOPIC IDENTIFICATION TESTS | NEAR-INFRARED AND RAMAN SPECTROSCOPY | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change (see Near-Infrared Spectroscopy—Theory and Practice 〈1856〉), to: (see 〈856〉), AND Change (see Chemometrics 〈1039〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and Raman Spectroscopy—Theory and Practice… Read More |
<197> SPECTROSCOPIC IDENTIFICATION TESTS | EQUIVALENT/ALTERNATIVE TESTS | USPNF 2021 ISSUE 1 | Online | 27-Aug-2021 | 1-Sep-2021 | NA | NA | Change (see Mass Spectrometry 〈736〉, Nuclear Magnetic Resonance Spectroscopy 〈761〉, 〈854〉, 〈857〉, 〈941〉, Near-Infrared Spectroscopy—Theory and Practice 〈1856〉, and 〈858〉. to: (see Mass Spectrometry 〈736〉, Nuclear… Read More |
<198> NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY IDENTITY TESTING OF BACTERIAL POLYSACCHARIDES USED IN VACCINE MANUFACTURE | 2. PROCEDURE | First Supplement to USP41–NF36 | 8633 | 29-Jun-2018 | 1-Jul-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 3 of 2.1 Equipment Requirements/Processing Parameters: Change adsorption to: absorption |
<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS | BUFFER AND MEDIA/Media | USP42–NF37 | 8514 | 25-Oct-2019 | 1-Nov-2019 | NA | NA | In Row 5 of Column 2 for L-Cystine in Fluid Selenite–Cystine Medium: Change 10.0 g to: 10.0 mg |
<207> TEST FOR 1,6-ANHYDRO DERIVATIVE FOR ENOXAPARIN SODIUM | PROCEDURES/Procedure | USP41–NF36 | 6108 | 28-Sep-2018 | 1-Oct-2018 | USP43–NF38 | Second Supplement to USP41–NF36 | Line 2 of Reduction suitability test: Change 0.02%. to: 0.02. |
<208> ANTI-FACTOR XA AND ANTI-FACTOR IIA ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS | Anti-Factor Xa and Anti-Factor IIa Assays for Low Molecular Weight Heparins | USP43–NF38 | 6611 | 31-Jul-2020 | 1-Aug-2020 | NA | NA | Change Anti-Factor Xa Activity for Low Molecular Weight Heparin to: The following procedure is used where specified in the individual monographs. This assay can be performed manually in plastic tubes utilizing heated block stations or water bath.… Read More |
<209> LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS | PROCEDURE | USPNF Online | Online | 31-Mar-2023 | 1-Apr-2023 | NA | NA | In footnote 1 in Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography/Chromatographic system/Columns/Analytical: Change guard column TSK SWXL 6-mm × 4-mm; to: guard column TSK… Read More |
<210> MONOSACCHARIDE ANALYSIS | PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids | First Supplement to USP41–NF36 | Online | 25-May-2018 | 1-Jun-2018 | USP42–NF37 | Second Supplement to USP41–NF36 | Line 6 of Analysis: Change Convert the protein concentration from mg/mL to (1 μM = 1 nmol/mL). to: Convert the protein concentration from mg/mL to μM (1 μM = 1 nmol/mL). |
<210> MONOSACCHARIDE ANALYSIS | PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids | First Supplement to USP40–NF35 | 8059 | 28-Jul-2017 | 1-Aug-2017 | USP42–NF37 | First Supplement to USP41–NF36 | Line 6 of Analysis: Change (1 M = 1nmol/mL). to: (1 µM = 1nmol/mL). |
<212> OLIGOSACCHARIDE ANALYSIS | SEPARATION AND IDENTIFICATION OF OLIGOSACCHARIDES | USP40–NF35 | 273 | 26-May-2017 | 1-Jun-2017 | USP41–NF36 | USP41–NF36 | Line 1 of Normal Phase Chromatography/HILIC/Ammonium formate buffer: Change Add 1.4 M ammonia solution to 1.4 M formic acid solution. to: Add 1.4 M ammonia solution to 1.4 M formic acid solution until a pH of 4.4 is obtained. |
<228> ETHYLENE OXIDE AND DIOXANE | Method II | USP36–NF31 | 148 | 31-May-2013 | 1-Jun-2013 | USP37–NF32 | USP37–NF32 | Line 31 of Analysis: Change rS = ethylene oxide peak responses from Standard solution B to: rS = dioxane peak responses from Standard solution B |
<232> ELEMENTAL IMPURITIES--LIMITS | DRUG SUBSTANCE AND EXCIPIENTS/Table 2 | Second Supplement to USP38–NF33 | 7594 | 29-May-2015 | 1-Jun-2015 | USP39–NF34 | USP39–NF34 | Line 1 of Row 1 of Column 2: Change (g/g) to: (µg/g) AND Line 1 of Row 1 of Column 3: Change (g/g) to: (µg/g) AND Line 1 of Row 1 of Column 4: Change (g/g) to: (µg/g) |
<232> ELEMENTAL IMPURITIES--LIMITS | Drug Products/Large Volume Parenterals | Second Supplement to USP35–NF30 | 5633 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Row 16 of Column 4 of Table 1: Change 70 to: 100 AND Row 16 of Column 5 of Table 1: Change 25 to: 10 |
<232> ELEMENTAL IMPURITIES--LIMITS | Drug Substance and Excipients | Second Supplement to USP35–NF30 | 5633 | 31-Jan-2013 | 1-Feb-2013 | USP37–NF32 | Second Supplement to USP36–NF31 | Row 16 of Column 4 of Table 2: Change 7 to: 10 |
<232> ELEMENTAL IMPURITIES—LIMITS | DRUG SUBSTANCE AND EXCIPIENTS | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Rows 11 and 15 of Column 2 of Table 2: Change 100 to: 10 AND Rows 11 and 15 of Column 3 of Table 2: Change 10 to: 1.0 AND Row 11 of Column 4 of Table 2: Change 1.5 to: 0.15 AND Row 15 of Column 4 of Table 2:… Read More |
<232> ELEMENTAL IMPURITIES—LIMITS | ANALYTICAL TESTING | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 6: Change Pd to: Pb |
<232> ELEMENTAL IMPURITIES—LIMITS | DRUG SUBSTANCE AND EXCIPIENTS | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Row 13 of Column 4 of Table 2: Change 25 to: 1.0 |
<232> ELEMENTAL IMPURITIES—LIMITS | DRUG PRODUCTS/Large Volume Parenterals | Second Supplement to USP35–NF30 | 5633 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Row 13 of Column 4 of Table 1: Change 250 to: 10 |
<232> ELEMENTAL IMPURITIES—LIMITS | DRUG PRODUCTS/Options for Demonstrating Compliance | USP36–NF31 | 151 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 17 of Summation Option: Change the manufacturer must validate to: the manufacturer must ensure |
<232> ELEMENTAL IMPURITIES—LIMITS | ANALYTICAL TESTING | USP36–NF31 | 151 | 27-Sep-2013 | 1-Oct-2013 | USP38–NF33 | First Supplement to USP37–NF32 | Line 2: Change If, by validated processes and supply-chain control, to: If, by process monitoring and supply-chain control, |
<233> ELEMENTAL IMPURITIES—PROCEDURES | INTRODUCTION/Definition | Second Supplement to USP35–NF30 | 5634 | 28-Sep-2012 | 1-Oct-2012 | USP37–NF32 | First Supplement to USP36–NF31 | Line 2 of Target Elements: Change Pd to: Pb |
<251> LEAD | PROCEDURES/Procedure 1: Chemical Method | USPNF Online | Online | 27-Jan-2023 | 1-Jun-2023 | NA | NA | In Analysis: Change Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonia cyanide solution, to: Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonium cyanide… Read More |
<251> LEAD | REQUIREMENTS FOR PROCEDURE VALIDATION | USPNF Online | Online | 27-Jan-2023 | 1-Jun-2023 | NA | NA | Change • Precision Repeatability to: • Precision |