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PDF CSV May 16, 2022 through May 16, 2024 All Errata for USP–NF How to use
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Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Sort descending Target Online Fix Publication Description
<197> SPECTROSCOPIC IDENTIFICATION TESTS NEAR-INFRARED AND RAMAN SPECTROSCOPY USPNF 2021 ISSUE 1 Online 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
PRAZOSIN HYDROCHLORIDE COMPOUNDED ORAL SUSPENSION ASSAY/Procedure Second Supplement to USP41–NF36 8945 1-Mar-2019 NA NA In the Mobile phase: Change
tetramethylammonium hydrochloride
to:
tetramethylammonium hydroxide
ECONAZOLE NITRATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Mar-2022 NA NA In USP Econazole Related Compound B RS: Change
Econazole amine;
2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine.
C15H14Cl3NO 330.64
to:
Econazole amine;
2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)… Read More
<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 solution
to:… Read More
POWDERED FORSKOHLII COMPOSITION/Content of Forskolin USPNF Online Online 1-Aug-2022 NA NA In Chromatographic system: Change
Column: 4.6-mm × 25-cm; 5-µm, 100 Å
to:
Column: 4.6-mm × 25-cm; 5-µm, 100 Å; packing L1
<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
AZTEC MARIGOLD ZEAXANTHIN EXTRACT COMPOSITION/Procedure 4: Stereoisomeric Composition USPNF Online Online 1-Feb-2023 NA NA In System suitability/Suitability requirements/Resolution: Change
(3R,3′S meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
AND
In Analysis: Change
(3R,3′S Read More
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS TABLETS STRENGTH USP43–NF38 5476 1-May-2020 NA NA In the Calculate statement in Niacin or Niacinamide, Pyridoxine Hydrochloride, Riboflavin, and Thiamine, Method 1/Analysis: Delete
, calcium pantothenate (C18H32CaN2O10), and folic acid (C19… Read More
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 1-Jul-2023 NA NA In Buffer stage/Analysis: Change
Calculate the percentage of the labeled amount of risedronate sodium (C7H10NNaO7P7) dissolved:
to:
Calculate the percentage of the labeled amount of risedronate… Read More
CLOMIPHENE CITRATE IDENTIFICATION/B. USP43–NF38 1088 1-Oct-2020 NA NA Change
Spectroscopic Identification Tests 〈197〉, Ultraviolet Spectroscopy: 197U
to:
Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U
Strychnine Sulfate REAGENTS AND REFERENCE TABLES USPNF Online Online 1-Dec-2023 NA NA In Reagent Specifications: Change
CAS RN®: 60-41-3.
to:
CAS RN®: 60491-10-3.
DOBUTAMINE IN DEXTROSE INJECTION ASSAY/Procedure 1: Dextrose USP43–NF38 1470 1-Jan-2021 NA NA In Analysis: Change
Result = [(100 × a) × (l/α)] × (1/CU) × (Mr1/Mr2) × 100
to:
Result = [(100 × a)/(l × α)] × (1/CU) × (Mr1… Read More
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> Revision Bulletin (Official March 01, 2021) Online 1-Jul-2021 NA NA In Test 14/Analysis: Delete
Result4 = {(C4 × V) + [(C3 + C2 + C1) × VS]} × (1/L) × 100
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <11>/Test 3/Buffer stage Revision Bulletin (Official March 01, 2018) Online 1-Jan-2019 NA NA In the Standard solution: Change
0.25 M sodium hydroxide,
to:
0.25 N sodium hydroxide,
AND
In the Sample solution: Change
0.25sodium hydroxide,
to:
0.25 N sodium hydroxide,
ELEUTHERO ROOT AND RHIZOME POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF 2021 ISSUE 1 Online 1-Dec-2021 NA NA Change
USP Eleutheroside B RS
β-D-Glucopyranoside, 4-(3-hydroxy-1-propenyl)-2,6-dimethoxyphenyl.
C17H24O9 372.37
USP Eleutheroside E RS
β-D-Glucopyranoside, (tetrahydro-1H,3H-furo(3,4-c)furan-1,4-… 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
In example… Read More
AZITHROMYCIN FOR ORAL SUSPENSION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2022 NA NA In USP Azithromycin Related Compound F RS: Change
762.97
to:
762.98
AND
In USP Desosaminylazithromycin RS: Change
590.79
to:
590.80
<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 MminRead More
DOXORUBICIN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USPNF 2022 Online Online 1-Nov-2022 NA NA In Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
REPOSITORY CORTICOTROPIN INJECTION ADDITIONAL REQUIREMENTS USP43–NF38 1174 1-May-2020 NA NA In USP Reference Standards <11>: Add
USP Ascorbic Acid RS
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS IMPURITIES/Limit of 2-Methylbenzhydrol USPNF Online Online 1-Apr-2023 NA NA In Standard solution: Change
7.5 µg/mL of USP 2-Methylbenzhydrol RS in methanol
to:
7.5 µg/mL of USP Methylbenzhydrol RS in methanol
AND
In Analysis: Change
CS = concentration of USP 2-Methylbenzhydrol RS in the… Read More
AMLODIPINE AND ATORVASTATIN TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Revision Bulletin (Official November 27, 2019) Online 1-Jul-2020 NA NA In USP Atorvastatin Related Compound B RS: Change
(3S,5R)-7-[3-(Phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calcium salt.
to:
Calcium (3S,5R)-7-[2-(4-… Read More
ZIPRASIDONE CAPSULES PERFORMANCE TESTS USPNF Online Online 1-Sep-2023 NA NA In Dissolution 〈711〉/Test 1/Tier 1/Phosphate buffer, pH 7.5: Change
sodium hydroxide
to:
sodium hydroxide solution
AND
In Dissolution 〈711〉/Test 1/Tier 1/Analysis: Change
449.40
to… Read More
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS ASSAY/Procedure First Supplement to USP43–NF38 Online 1-Nov-2020 NA NA In Buffer A: Change
monobasic potassium phosphate
to:
monobasic sodium phosphate
<661.1> PLASTIC MATERIALS OF CONSTRUCTION POLYAMIDE 6 First Supplement to USP43–NF38 Online 1-Dec-2020 NA NA In Related Substances/Chromatographic system/Column: Change
0.25-mm × 0.25-µm; phase G25
to:
30-m × 0.25-mm; 0.25-µm phase G25
OIL- AND WATER-SOLUBLE VITAMINS WITH MINERALS CHEWABLE GELS STRENGTH USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA In Vitamins B3 (as Niacinamide), B6, and Folic Acid, Method 1/System suitability: Change
[Note—The relative retention times for niacinamide, pyridoxine, and folic acid are about 1.0, 1.6, 2.0, and 3.0 respectively.]
to:
[Note—The relative… Read More
SACCHARIN SPECIFIC TESTS/Readily Carbonizable Substances Test <271> USPNF 2021 ISSUE 1 Online 1-Oct-2021 NA NA In Matching fluid A: Change
Cobaltous chloride CS, ferric chloride TS, cupric sulfate CS, and water (0.1:0.4:0.1:4.4)
to:
Cobaltous chloride CS, ferric chloride CS, cupric sulfate CS, and water (0.1:0.4:0.1:4.4)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS ASSAY/Procedure/Chromatographic system First Supplement to USP42–NF37 Online 1-May-2019 NA NA In Column: Change
4.6-mm × 15-cm; 5-µm packing L7. [Note—Conditioning of the Column with Solution A and Solution B (90:10) (ERR 1-Mar-2019) for about 30 min is recommended prior to use.]
to:
4.6-mm × 15-cm… Read More
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
SAW PALMETTO EXTRACT COMPOSITION/Content of Long-Chain Alcohols and Sterols USP42–NF37 5196 1-Jul-2019 NA NA In System suitability stock solution B: Change
2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS and 0.37 mg/mL of stigmastanol
to:
0.37 mg/mL of stigmastanol and 2 mg/mL each of campesterol, stigmasterol, and USP β-Sitosterol RS in… Read More
0.1 N Potassium Permanganate VS STANDARDIZATION USPNF Online Online 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
<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
DEXAMETHASONE SODIUM PHOSPHATE INJECTION ASSAY/Procedure USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
Result = (rU/rS) × (CS/CU) × (Mr1/Mr22) × 100
to:
Result = (rU/r… Read More
<191> IDENTIFICATION TESTS—GENERAL CHEMICAL IDENTIFICATION TESTS USP43–NF38 6587 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
PIPERACILLIN SPECIFIC TESTS USPNF Online Online 1-Aug-2023 NA NA In Sterility Tests 〈71〉: Change
Where the label states that Piperacillin is sterile or that it must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements when tested as directed in Test for… Read More
NICOTINE TRANSDERMAL SYSTEM PERFORMANCE TESTS/Drug Release <724> USP43–NF38 3153 1-Oct-2020 NA NA In Tests 1, 2, 4, and 5/Tolerances: Change
conform to Dissolution <711>, Acceptance Table 1.
to:
conform to Acceptance Table 1.
DICYCLOMINE HYDROCHLORIDE IDENTIFICATION USPNF Online Online 1-Feb-2024 NA NA In B. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride: Change
Meets the requirements when tested as specified in test B.
to:
Meets the requirements of the test for amine… Read More
FENTANYL CITRATE CHEMICAL INFORMATION USPNF 2021 ISSUE 1 Online 1-May-2021 NA NA Change
528.59
to:
528.60
MYCOPHENOLATE MOFETIL TABLETS PERFORMANCE TESTS/Dissolution <711> USP43–NF38 3049 1-Aug-2021 NA NA In Test 3/Analysis: Change
Result = (rU/rS) × CS × D
rU = peak response from the Sample solution
rS = peak response from the… Read More
SALMETEROL INHALATION POWDER PERFORMANCE TESTS First Supplement to USP41–NF36 Online 1-Feb-2019 NA NA In the definition list in Particle Size Distribution by Cascade Impaction/Analysis: Change
Mr1 = molecular weight of salmeterol free base, 415.75
to:
Mr1 = molecular weight of salmeterol… Read More
CARBOPLATIN FOR INJECTION IMPURITIES/Limit of 1,1-Cyclobutanedicarboxylic Acid USPNF 2021 ISSUE 1 Online 1-Jan-2022 NA NA In Chromatographic system/Column: Change
4.0-mm × 30-cm; packing L1
to:
3.9-mm × 30-cm; packing L1
DOXORUBICIN HYDROCHLORIDE ASSAY/Procedure USP42–NF37 1481 1-Jun-2019 NA NA In the Analysis: Change
P = potency of doxorubicin in USP Doxorubicin Hydrochloride RS (µg/mg)
to:
P = potency of doxorubicin hydrochloride in USP Doxorubicin Hydrochloride RS (µg/mg)
DOXYCYCLINE HYCLATE CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jul-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide… 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
CHLORHEXIDINE GLUCONATE ORAL RINSE IMPURITIES/Limit of p-Chloroaniline USPNF Online Online 1-Dec-2022 NA NA Change
Standard solution: 1.0 µg/mL of USP p-Chloroaniline RS in Diluent
to:
Standard solution: 0.001 mg/mL of USP p-Chloroaniline RS in Diluent
AND
In Analysis: Change
Result = (rU Read More
MENADIONE ASSAY/Procedure USP43–NF38 2780 1-May-2020 NA NA In Endpoint detection: Change
Potentiometric
to:
Visual
POLYETHYLENE GLYCOL 12 CETOSTEARYL ETHER IDENTIFICATION USPNF Online Online 1-Aug-2023 NA NA Change:
B. Test for Hydroxyl Group:
to:
B. Hydroxyl Value:
AND
In D./Analysis: Change
Dissolve or disperse the Sample in alcohol.
to:
Dissolve or disperse the Read More
<1125> NUCLEIC ACID-BASED TECHNIQUES—GENERAL APPENDICES/Appendix 1 USP43–NF38 7865 1-Aug-2020 NA NA In footnote 1: Change
http://ts.nist.gov/measurementservices/referencematerials/index.cfm.
to:
https://www.nist.gov/srm.
METHYLBENZETHONIUM CHLORIDE ASSAY USPNF Online Online 1-Nov-2023 NA NA In Procedure/Analysis: Change
Calculate the percentage of methylbenzethonium chloride (C28H44ClNO2 · H2O) in the portion of Methylbenzethonium Chloride taken:
to:
Calculate the percentage of… Read More
DAPSONE TABLETS PERFORMANCE TESTS USPNF Online Online 1-May-2024 NA NA In Dissolution 〈711〉/Standard solution: Change
USP Dapsone RS of a known concentration in Medium
to:
(L/1000) mg/mL of USP Dapsone RS in Medium, where L is the label claim in mg/Tablet. Transfer a portion of this… Read More