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PDF CSV November 18, 2017 through November 18, 2019 See 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
<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
<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
<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
<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
<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 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
<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
<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
<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.
<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
<2022> MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS BUFFER AND MEDIA/Media USP42–NF37 8514 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 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 2 of Reduction suitability test: Change
0.02%.
to:
0.02.
<210> MONOSACCHARIDE ANALYSIS PROCEDURES/Procedure 3: Enzymatic Hydrolysis and Analysis by RP-HPLC of DMB-labeled Sialic Acids First Supplement to USP41–NF36 Online 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).
<381> ELASTOMERIC CLOSURES FOR INJECTIONS PHYSICOCHEMICAL TESTS/Heavy Metals Revision Bulletin (Official January 01, 2018) Online 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… Read More
<41> BALANCES REPEATABILITY First Supplement to USP42–NF37 9011 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 M… Read More
<466> ORDINARY IMPURITIES KEY FOR VISUALIZATION TECHNIQUES USP41–NF36 Online 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… Read More
<55> BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS D-VALUE DETERMINATION USP42–NF37 6385 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 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… Read More
<581> VITAMIN D ASSAY ASSAY/Procedure 8 First Supplement to USP41–NF36 Online 1-Oct-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 1 of Aqueous potassium hydroxide solution: Change
800 mg
to:
800 g
<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 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
<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS USP41–NF36 6403 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 TEST METHODS/Tin in Non-Tin-Stabilized Materials USP41–NF36 6403 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
<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
<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 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 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 =
<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,
<855> NEPHELOMETRY AND TURBIDIMETRY 4. INSTRUMENTATION USP42–NF37 7059 1-May-2019 NA NA In paragraph 2: Change
silicone diodes
to:
silicon diodes
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… Read More
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 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
ALLOPURINOL ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41–NF36 121 1-Dec-2018 USP43–NF38 USP42–NF37 Line 3 of USP Allopurinol Related Compound A RS: Change
(C5H6N4O)2 · H2SO4 350.32
to:
(C4H6N4O)2 · H2SO4 350.31
ALMOTRIPTAN MALATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Interim Revision Announcement (Official May 01, 2017) Online 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]pyrrolidine N-oxide.
C17H25N3O3S 351.46
to:
1-[({3-[2-(Dimethylamino)ethyl]indol-5-yl}methyl)sulfonyl]… Read More
ALMOTRIPTAN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Second Supplement to USP40–NF35 8708 1-Dec-2017 USP42–NF37 Second Supplement to USP41–NF36 Line 4 of USP Almotriptan Related Compound B RS: Change
C15H22N3O2S
to:
C15H21N3O2S
AND
Line 2 of USP Almotriptan Related Compound D RS: Change
1-[({3-[2-(Dimethylamino)ethyl]indol… Read More
ALPROSTADIL ASSAY/Procedure USP42–NF37 151 1-Aug-2019 NA NA In System suitability stock solution: Change
Standard solution
to:
Standard stock solution
ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> USP42–NF37 170 1-Aug-2019 NA NA Change
cfu/g
to:
cfu/mL
AMIKACIN SULFATE INJECTION ASSAY/Procedure USP41–NF36 203 1-Sep-2018 USP43–NF38 Second Supplement to USP41–NF36 Variable definition list in Analysis: Change
CU = nominal concentration of amikacin in the Sample solution
to:
CU = nominal concentration of amikacin in the Sample solution (mg/mL)
AMINOBENZOATE POTASSIUM IMPURITIES/Limit of Aniline and p-Toluidine USP41–NF36 209 1-Sep-2018 USP43–NF38 Second Supplement to USP41–NF36 Line 3 of System suitability: Change
[Note—The relative retention times of aniline and p-toluidine are about 4.1 and 5.1 min, respectively.]
to:
[Note—The relative retention times of aniline and p-toluidine are 0.8 and 1.0,… Read More
AMIODARONE HYDROCHLORIDE CHEMICAL INFORMATION USP42–NF37 253 1-Oct-2019 NA NA See https://www.uspnf.com/sites/default/files/usp_pdf/EN/september-2019-errata-with-image.pdf for correction.