Skip to main content

Errata - English

PDF CSV May 14, 2022 through May 14, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Sort descending Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
<724> DRUG RELEASE GENERAL DRUG RELEASE STANDARDS USP41–NF36 6471 1-May-2018 USP42–NF37 Second Supplement to USP41–NF36 Figure 5: Change
O
to:
Ø
<733> LOSS ON IGNITION INTRODUCTION USP43–NF38 Online 1-Nov-2020 NA NA In paragraph 3: Change
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room temperature before weighing.
to:
Upon completion of each ignition, cover the crucible, and allow it to cool in a desiccator to room… Read More
<795> PHARMACEUTICAL COMPOUNDING— NONSTERILE PREPARATIONS STABILITY CRITERIA AND BEYOND-USE DATING/General Guidelines for Assigning Beyond-Use Dates Revision Bulletin (Official January 01, 2014) Online 1-Apr-2014 Second Supplement to USP37–NF32 Second Supplement to USP37–NF32 Line 7 of Paragraph 1: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling)
to:
(see <659>)
<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS DEFINITIONS USP37–NF32 403 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Beyond-Use Date (BUD): Change
The date after which a compounded preparation should not to be used;
to:
The date after which a compounded preparation shall not be used;
<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS COMPOUNDING FACILITIES Revision Bulletin (Official January 01, 2014) Online 1-Apr-2014 Second Supplement to USP37–NF32 Second Supplement to USP37–NF32 Line 4 of Paragraph 4: Change
(see the General Notices and Requirements, Preservation, Packaging, Storage, and Labeling, Storage Temperature and Humidity;
to:
(see Packaging and Storage Requirements <659>;
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS APPENDICES/Appendix 3: Types of Biological Safety Cabinets/Class II First Supplement to USP39–NF34 7721 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 5 of Type A1 (formerly, Type A): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type A2 (formerly, Type B3): Change
radionucleotides
to:
radionuclides
AND
Line 5 of Type B1: Change
radionucleotides
to:
radionuclides
Read More
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 5. FACILITIES AND ENGINEERING CONTROLS/5.4 Containment Supplemental Engineering Controls First Supplement to USP40–NF35 Online 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 5 of paragraph 1: Change
containment reduction.
to:
contamination reduction.
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 7. PERSONAL PROTECTIVE EQUIPMENT First Supplement to USP40–NF35 Online 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of paragraph 2: Change
antineoplastic HDs.
to:
injectable antineoplastic HDs.
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 5. FACILITIES AND ENGINEERING CONTROLS/5.3 Compounding First Supplement to USP39–NF34 7721 1-Jun-2016 USP40–NF35 USP40–NF35 First bullet in second paragraph: Change
• Be externally vented through high-efficiency particulate air (HEPA) filtration
to:
• Be externally vented
<800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS REFERENCES First Supplement to USP39–NF34 7721 1-Oct-2016 USP41–NF36 First Supplement to USP40–NF35 Line 2 of first reference: Delete
http://www.acoem.org/Reproductive_Developmental_Hazard_Management.aspx.
AND
Line 2 of second reference: Delete
Read More
<800> HAZARDOUS DRUGS - HANDLING IN HEALTHCARE SETTINGS REFERENCES Revision Bulletin (Official December 01, 2017) Online 1-Sep-2018 USP43–NF38 Second Supplement to USP41–NF36 Reference 37: Delete
http://www.osha.gov/Publications/osha3151.html.
<81> ANTIBIOTICS—MICROBIAL ASSAYS APPENDIX 1. FORMULAS FOR MANUAL CALCULATIONS OF REGRESSION AND SAMPLE CONCENTRATION USP38–NF33 133 1-Oct-2015 USP40–NF35 First Supplement to USP39–NF34 Line 19: Change
b = [(4 × 17.222) + (2 × 16.511) − (2 × 14.989) − (4 × 14.020)]/{5[ln(7.81)] − ln(3.2)} = 3.551
to:
b = [(4 × 17.222) + (2 × 16.511) − (2 × 14.989) − (4 × 14.020)]/{5[ln(7.81) − ln(3.2)]} = 3.551
<81> ANTIBIOTICS—MICROBIAL ASSAYS APPENDICES USPNF Online Online 1-Jan-2024 NA NA In two instances in Appendix 1 equations: Change
14.020
to:
14.022
<81> ANTIBIOTICS—MICROBIAL ASSAYS Turbidimetric Method USP36–NF31 76 1-Apr-2014 USP38–NF33 USP38–NF33 Line 9 of Paragraph 2 of Analysis: Change
or a water bath maintained at the temperature specified in Table 8 and for the time specified in Table 11.
to:
or a water bath maintained at 36.0° –37.5° for the time specified in Table 11.
<81> Antibiotics—Microbial Assays Turbidimetric Method USP35–NF30 74 1-Dec-2012 USP37–NF32 Second Supplement to USP36–NF31 Line 8 of Analysis: Change
Include in each rack 1–2 control tubes containing 1 mL of the inoculum medium (see Table 8) but no antibiotic.
to:
Include in each rack 1–2 control tubes containing 1 mL of the test diluent (see Table 7) but no antibiotic.
<81> ANTIBIOTICS—MICROBIAL ASSAYS CALCULATIONS/Turbidimetric Assay/Sample Data USP40–NF35 143 1-Mar-2018 USP42–NF37 Second Supplement to USP41–NF36 Second equation in Step 1: Change
0.0125 =
to:
0.0062 =
AND
Third equation in Step 1: Change
0.0325 =
to:
0.0322 =
<852> ATOMIC ABSORPTION SPECTROSCOPY VALIDATION AND VERIFICATION/Precision/Intermediate Precision USP38–NF33 649 1-Dec-2015 USP40–NF35 Second Supplement to USP39–NF34 Line 3: Change
As a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).
to:
As a minimum, the analytical procedure should be assessed by performing the repeatability test in… Read More
<855> NEPHELOMETRY AND TURBIDIMETRY 4. INSTRUMENTATION USP42–NF37 7059 1-May-2019 NA NA In paragraph 2: Change
silicone diodes
to:
silicon diodes
<855> NEPHELOMETRY AND TURBIDIMETRY 5. FORMAZIN TURBIDITY STANDARDS USP42–NF37 7059 1-May-2019 NA NA In paragraph 1: Change
IUPAC Compendium of Chemical Technology,
to:
IUPAC Compendium of Chemical Terminology,
<856> NEAR-INFRARED SPECTROSCOPY 4. VALIDATION AND VERIFICATION USP43–NF38 7161 1-May-2020 NA NA In 4.1 Validation/4.1.1 Accuracy/Validation criteria/Criteria 1: Change
Suitable agreement between SEP
to:
Suitable agreement between the standard error of prediction (SEP)
<857> ULTRAVIOLET-VISIBLE SPECTROSCOPY QUALIFICATION OF UV-VIS SPECTROMETERS Second Supplement to USP42–NF37 9570 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
<871> SUTURES--NEEDLE ATTACHMENT PROCEDURE USPNF Online Online 1-Aug-2022 NA NA In Removable Needle Attachment: Change
For USP sizes 5-0 through 2-0,
to:
For USP sizes 5-0 through 2,
<915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY APPARATUS USPNF Online Online 1-Dec-2023 NA NA In Figure 2: Change
66±0.25 Ø
to:
65±0.25 Ø
N-Benzoyl-L-arginine Ethyl Ester Hydrochloride REAGENT SPECIFICATIONS USPNF Online Online 1-Dec-2022 NA NA Change
Crystallized Trypsin (USP Monograph).
to:
Trypsin (USP Monograph).
ABIRATERONE ACETATE TABLETS PERFORMANCE TESTS/Dissolution <711>/Test 3 Revision Bulletin (Official November 19, 2019) Online 1-Jul-2020 NA NA In Analysis: Change
rU = peak response of abiratrone acetate from the Sample solution
rS = peak response of abiratrone acetate from the Standard solution
to:
rU = peak… Read More
ACAMPROSATE CALCIUM IMPURITIES/Limit of Acamprosate Related Compound A First Supplement to USP41–NF36 8263 1-Dec-2018 USP43–NF38 USP42–NF37 In the variable definition list in Analysis: Change
CS = concentration of USP Acamprosate Calcium Related Compound A RS in the Standard solution (µg/mL)
to:
CS = concentration of USP Acamprosate Related… Read More
ACARBOSE IMPURITIES USPNF Online Online 1-Jan-2024 NA NA In Chromatographic Purity/Analysis: Change
Result = (rU/rA) × (1/F) × 100
to:
Result = (rU/rA) × (1/F)
ACARBOSE TABLETS IDENTIFICATION/B. USPNF Online Online 1-May-2023 NA NA Change
The spectrum obtained from the Sample solution shows IR maxima in the regions of 3500–3200, 2950–2890, 1653–1633, and 1070–1000 cm–1.
to:
The spectrum obtained from the sample preparation shows IR maxima in the regions of 3500–3200… Read More
ACESULFAME POTASSIUM IMPURITIES/Limit of Fluoride USP35–NF30 1680 1-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31 Line 25 of Analysis: Change
C = concentration of fluoride in the Sample solution, from the standard curve (mg/mL)
to:
C = concentration of fluoride in the Sample solution, from the standard curve (µg/mL)
ACETAMINOPHEN AND CODEINE PHOSPHATE CAPSULES PERFORMANCE TESTS First Supplement to USP40–NF35 8201 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the Calculate statement of Uniformity of Dosage Units <905>/Procedure for content… Read More
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PERFORMANCE TESTS First Supplement to USP40–NF35 8202 1-Aug-2017 USP42–NF37 First Supplement to USP41–NF36 Line 1 of Dissolution <711>/Analysis:Change
Determine the labeled amount of acetaminophen
to:
Determine the percentage of the labeled amount of acetaminophen
AND
In the second Calculate statement in Uniformity of Dosage Units <905>/Procedure for… Read More
ACETAMINOPHEN ORAL SUSPENSION IMPURITIES/Organic Impurities Revision Bulletin (Official August 01, 2018) Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 This erratum applies to the new USP-NF ONLINE platform only.
Change
Solution B: 0.2% trifluoroacetic acid in water
to:
Solution B: 0.2% trifluoroacetic acid in acetonitrile
ACETAMINOPHEN ORAL SUSPENSION ASSAY Second Supplement to USP41–NF36 Online 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)
ACETAMINOPHEN SUPPOSITORIES ASSAY/Procedure USP37–NF32 1567 1-Jun-2014 USP38–NF33 USP38–NF33 Line 6 of Sample stock solution: Change
add 30 mL of hexane,
to:
add 30 mL of solvent hexane,
AND
Line 10 of Sample stock solution: Change
wash the hexane
to:
wash the solvent hexane
ACETAMINOPHEN TABLETS IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Oct-2021 NA NA In Chromatographic system/Detector: Change
UV 272 nm. For Identification B, use a diode array detector in the range of 200–400 nm.
to:
UV 272 nm
ACETAZOLAMIDE FOR INJECTION ASSAY USP35–NF30 2063 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 19: Change
25C(AU/AS)
to:
250C(AU/AS)
ACETYLCYSTEINE SOLUTION ASSAY/Procedure USP40–NF35 2586 1-Jun-2017 USP41–NF36 USP41–NF36 Line 3 of Sample solution: Change
Standard stock solution
to:
Sample stock solution
ACETYLTRIBUTYL CITRATE IDENTIFICATION/B. USP36–NF31 1869 1-Oct-2013 USP38–NF33 First Supplement to USP37–NF32 Line 2: Change
USP Acetyltriethyl Citrate RS
to:
USP Acetyltributyl Citrate RS
ACYCLOVIR ASSAY/Procedure USPNF Online Online 1-May-2023 NA NA In the Sample solution: Change
0.1 N sodium hydroxide
to:
0.01 N sodium hydroxide
ACYCLOVIR FOR INJECTION IMPURITIES/Procedure USPNF Online Online 1-Apr-2022 NA NA In Standard solution A: Change
0.5 μg/mL of Acyclovir standard solution in Solution A
to:
0.5 μg/mL of USP Acyclovir RS from Acyclovir standard solution in Solution A
AND
In Standard solution B:… Read More
ADAPALENE IMPURITIES/Residual Solvent: Limit of Triethylamine Revision Bulletin (Official December 01, 2012) Online 1-Feb-2013 USP37–NF32 Second Supplement to USP36–NF31 Line 1 of Diluent: Change
Dimethyl sulfoxide and 1 N sodium hydroxide solution (4:1)
to:
Dimethyl sulfoxide
AND
Line 1 of Standard solution: Change
3.2 μg/mL of USP Triethylamine RS in Diluent
to:
4.0 μg/mL of USP Triethylamine RS in Diluent.… Read More
ADAPALENE GEL ASSAY/Procedure First Supplement to USP39–NF34 7983 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 5 of Sample stock solution: Change
Cool to room temperature and dilute with Diluent to volume.
to:
Cool to room temperature and dilute with Mobile phase to volume.
ADENINE CHEMICAL INFORMATION USP39–NF34 2346 1-Feb-2017 USP41–NF36 Second Supplement to USP40–NF35 Line 2: Change
1H-Purin-6-amine;
to:
9H-Purin-6-amine;
ADENOSINE IDENTIFICATION/Infrared Absorption <197M> USP35–NF30 2079 1-Oct-2012 USP37–NF32 First Supplement to USP36–NF31 Line 1:
Delete NMT 0.1%
ADIPIC ACID IMPURITIES/Related Substances USPNF Online Online 1-Dec-2022 NA NA In Table 2: Change
Pimelic acid 1.21 0.91
Valeric acid 1.21 0.91
to:
Pimelic acid 1.21 0.91
Valeric acid 1.46 0.88
ALBUTEROL SULFATE Chromatographic purity USP36–NF31 2352 1-Jun-2013 USP37–NF32 USP37–NF32 Line 1: Change
It meets the requirements of the test for Chromatographic purity under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Test solution.
to… Read More
ALCOHOL IN DEXTROSE INJECTION ASSAY/Dextrose USP37–NF32 1637 1-Jun-2014 USP38–NF33 USP38–NF33 Line 15 of Analysis: Change
A = length of the polarimeter tube (mm)
to:
A = 100 mm divided by the length of the polarimeter tube (mm)
ALCOHOLOMETRIC TABLE INTRODUCTION USPNF 2021 ISSUE 3 Online 1-Dec-2021 NA NA Change
Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that contains 95% alcohol by weight or 92.42% alcohol v/v.
to:
Similarly, a specific gravity value of 0.8092 in column 1 corresponds to a solution that… Read More
ALFADEX CHEMICAL INFORMATION USP42–NF37 5561 1-Feb-2020 NA NA Change
972.84
to:
972.85
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities USPNF 2021 ISSUE 1 Online 1-Nov-2021 NA NA In Analysis: Change
rS = peak response of alfuzosin from the Sample solution
to:
rS = peak response of alfuzosin from the Standard solution