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PDF CSV December 7, 2017 through December 7, 2019 All Errata for USP–NF How to use
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Monograph Title Sort descending Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
0.1 N POTASSIUM HYDROXIDE VS REAGENTS AND REFERENCE TABLES/Solutions USP42–NF37 6185 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… Read More
2,5-DIHYDROXYBENZOIC ACID REAGENTS AND REFERENCE TABLES/Reagent Specifications USP42–NF37 6097 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 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 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 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 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
<1047> GENE THERAPY PRODUCTS APPENDIX USP38–NF33 883 1-Jun-2015 USP39–NF34 USP39–NF34 Line 8 of National and International Regulatory Documents: Delete
(http://www4.od.nih.gov/oba/guidelines.html)
<1047> GENE THERAPY PRODUCTS REGULATIONS AND STANDARDS USP38–NF33 883 1-Jun-2015 USP39–NF34 USP39–NF34 Line 8: Delete
and, in particular, www.fda.gov/cber/publications.htm
<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 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
<1052> BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS APPENDIX USP36–NF31 619 1-Jun-2013 USP37–NF32 USP37–NF32 Change the section title
Method 6—Postcolumn DABS-CI Derivatization
to:
Method 6—Precolumn DABS-CI Derivatization
<1052> BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS METHODOLOGIES OF AMINO ACID ANALYSIS GENERAL PRINCIPLES USP36–NF31 619 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
<1056> BIOTECHNOLOGY-DERIVED ARTICLES -- POLYACRYLAMIDE GEL ELECTROPHORESIS INTRODUCTION Harmonization (Official December 01, 2015) Online 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… Read More
<1058> ANALYTICAL INSTRUMENT QUALIFICATION ANALYTICAL INSTRUMENT QUALIFICATION PROCESS/Qualification Phases First Supplement to USP40–NF35 8083 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 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 1-Apr-2013 USP37–NF32 USP37–NF32 Line 1 of footnote 1: Change
JP Edmond,
to:
JP Emond,
<1103> IMMUNOLOGICAL TEST METHODS—ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) PROCEDURES/Solid Phase USP40–NF35 1344 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
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL APPENDICES/Appendix 1: Regulations and Standards USP40–NF35 1471 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)
<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 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… Read More
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE 19. MEAN KINETIC TEMPERATURE USP42–NF37 7831 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 10. ALLIGATION ALTERNATE AND ALGEBRA METHODS FOR COMBINING MULTIPLE STRENGTHS OF THE SAME ACTIVE PHARMACEUTICAL INGREDIENT USP42–NF37 7831 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… Read More
<1160> PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE 19. MEAN KINETIC TEMPERATURE/19.2 MKT Equation USP42–NF37 7831 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 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 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 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 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 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 ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 6054 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 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 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,
<1228.4> DEPYROGENATION BY RINSING ROUTINE PROCESS CONTROL USP42–NF37 8067 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 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 USP42–NF37 6478 1-Aug-2019 NA NA In Standard stock solution: Change
0.4 µg/mL
to:
4 µg/mL
<123> GLUCAGON BIOIDENTITY TESTS PROCEDURE/B. In Vitro Cell-Based Bioidentity Test First Supplement to USP41–NF36 8627 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.… Read More
<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating Instructions USP40–NF35 216 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 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> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL 1. OVERVIEW: GENERAL CHAPTERS BASED ON SCATTERING PHENOMENA Second Supplement to USP42–NF37 9634 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
<1601> PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS AERODYNAMIC ASSESSMENT OF NEBULIZED AEROSOLS USP41–NF36 7874 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
<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 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 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 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… Read More
<1663> ASSESSMENT OF EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS REFERENCES USP41–NF36 7910 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 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 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 1-Aug-2016 USP41–NF36 First Supplement to USP40–NF35 Delete reference 8.
<1724> SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS IN VITRO PERFORMANCE TESTS USP39–NF34 1869 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> 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 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 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 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… Read More
<1790> VISUAL INSPECTION OF INJECTIONS 2. BACKGROUND/2.2 Patient Risk First Supplement to USP40–NF35 8099 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/Thiosulfate Second Supplement to USP40–NF35 Online 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.
<198> NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY IDENTITY TESTING OF BACTERIAL POLYSACCHARIDES USED IN VACCINE MANUFACTURE 2. PROCEDURE First Supplement to USP41–NF36 8633 1-Jul-2018 USP42–NF37 Second Supplement to USP41–NF36 Line 3 of 2.1 Equipment Requirements/Processing Parameters: Change
adsorption
to:
absorption