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PDF CSV March 28, 2022 through March 28, 2024 See all Errata for USP–NF How to use
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<621> CHROMATOGRAPHY ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS USPNF Online Online 1-Dec-2022 NA NA In Liquid Chromatography: Isocratic Elution/Injection volume: Change
L2 = internal diameter of the column used (mm)
dc1 = particle size indicated in the monograph (µm)
dc2 =… Read More
METHYLENE BLUE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Sep-2022 NA USPNF 2023 Issue 2 In USP Azure B RS: Change
3-(Dimethylamino)-7-(methylamino)-phenothiazine-5-ium chloride.
to:
3-(Dimethylamino)-7-(methylamino)phenothiazin-5-ium chloride.
<659> PACKAGING AND STORAGE REQUIREMENTS GENERAL DEFINITIONS/Packaging Definitions Second Supplement to USP43–NF38 Online 1-Dec-2025 NA NA In Light-resistant container: Change
〈661.2〉, Functionality, Spectral Transmission Requirements for Light-Resistant Components and Systems.
to:
〈661.2〉, Functionality Test Method, Spectral Transmission Requirements for Light-… Read 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)
<565> BOTANICAL EXTRACTS PREPARATIONS USPNF Online Online 1-Jun-2022 NA NA In General Pharmacopeial Requirements/Pesticide Residues: Change
where L is the limit in the original article as listed in Table 4 (see Pesticide Residue Analysis under Articles of Botanical Origin <561>)… Read More
POWDERED FORSKOHLII EXTRACT 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
DOXORUBICIN HYDROCHLORIDE FOR INJECTION IMPURITIES/Organic Impurities USPNF 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)
MESO-ZEAXANTHIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2023 NA NA In USP meso-Zeaxanthin RS: Change
(3R,3′S-meso)-Zeaxanthin.
to:
(3R,3′S)-Zeaxanthin.
CALCIUM LACTATE CHEMICAL INFORMATION USPNF Online Online 1-Apr-2023 NA NA Change
Calcium lactate (1:2) hydrate
to:
Calcium lactate hydrate
AND
Change
Calcium lactate (1:2) pentahydrate
to:
Calcium lactate pentahydrate
ATORVASTATIN CALCIUM TABLETS ASSAY/Procedure USPNF Online Online 1-Jul-2023 NA NA In Analysis: Change
Mr1 = molecular weight of atorvastatin, 558.64
Mr2 = molecular weight of atorvastatin calcium, 1155.34
to:
Mr1 = molecular weight of atorvastatin, 558.65
M… Read More
FOSAMPRENAVIR CALCIUM TABLETS PERFORMANCE TESTS USPNF Online Online 1-Sep-2023 NA NA In Dissolution 〈711〉/Medium: Change
26.7 g/L of sodium acetate trihydrate in water. Add 133 mL of glacial acetic acid to this solution, and then dilute with water to 10 L; 900 mL.
to:
0.02 M sodium acetate buffer, pH 3.5, prepared as follows.… Read More
OLMESARTAN MEDOXOMIL TABLETS PERFORMANCE TESTS USPNF Online Online 1-Dec-2023 NA NA In Dissolution 〈711〉/Test 5/Apparatus 2: Change
50 rpm. Use peak vessels.
to:
50 rpm. Use apex vessels.
NANDROLONE DECANOATE ASSAY/Procedure USPNF Online Online 1-Jun-2022 NA NA In Analysis: Change
Calculate the percentage of Nandrolone Decanoate (C28H44O3) in the portion of Nandrolone Decanoate taken:
to:
Calculate the percentage of nandrolone decanoate (C28H44O… Read More
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
DOXORUBICIN HYDROCHLORIDE INJECTION ASSAY/Procedure USPNF 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)
AZTEC MARIGOLD ZEAXANTHIN EXTRACT IDENTIFICATION/C. USPNF Online Online 1-Feb-2023 NA NA Change
(3R,3′S meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
LEVORPHANOL TARTRATE TABLETS PERFORMANCE TESTS/Uniformity of Dosage Units 〈905〉 USPNF Online Online 1-Aug-2023 NA NA In Sample solution: Change
Nominally about 80 ug/mL of levorphanol tartrate in Diluent prepared as follows.
to:
Nominally about 80 µg/mL of levorphanol tartrate in Diluent prepared as follows.
ATORVASTATIN CALCIUM TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 1-Jul-2023 NA NA In Test 1, Test 3, Test 4, Test 5, and Test 6/Analysis: Change
Mr1 = molecular weight of atorvastatin, 558.64
Mr2 = molecular weight of atorvastatin calcium, 1155.34
to:
Read More
OCTOCRYLENE IDENTIFICATION USPNF Online Online 1-Sep-2023 NA NA In A./Acceptance criteria: Change
NMT 3.0%, calculated on the as-is basis
to:
Absorptivities, calculated on the as-is basis, do not differ by more than 3.0%.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS PERFORMANCE TESTS USPNF Online Online 1-Dec-2023 NA NA In Dissolution 〈711〉/Test 2/Acid stage: Change
Acid stage standard solution: (L/10) mg/mL of USP Pantoprazole Sodium RS from the Standard stock solution in Acid stage medium, where L is the label claim… 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
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
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
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS PERFORMANCE TESTS/Dissolution 〈711〉 USPNF Online Online 1-Apr-2023 NA NA In Test 2/Analysis: Change
CS = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (ug/mL) in the Standard solution
to:
CS = concentration of USP Norethindrone Acetate… Read More
ATORVASTATIN CALCIUM TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Jul-2023 NA NA In USP Atorvastatin Related Compound B RS: Change
1155.34
to:
1155.36
ZIPRASIDONE CAPSULES ASSAY USPNF Online Online 1-Sep-2023 NA NA In Procedure/Analysis: Change
449.40
to:
449.39
SODIUM SALICYLATE ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA In USP Reference Standards 〈11〉: Add
USP Phenol RS
DOXYCYCLINE HYCLATE CHEMICAL INFORMATION USPNF Online Online 1-Jun-2022 NA NA Change
1025.87
to:
1025.88
LATANOPROST ASSAY/Procedure USPNF Online Online 1-Dec-2022 NA NA Change
Standard solution: Transfer 2.0 mg/mL of USP Latanoprost RS into a suitable volumetric flask, dissolve in dehydrated alcohol equivalent to 20% of the final volume, and dilute with chromatographic hexane to volume.
Sample solution:… Read More
DOFETILIDE CHEMICAL INFORMATION USPNF Online Online 1-Nov-2022 NA NA Change
β-[(p-Methanesulfonamidophenethyl)methylamino]methane sulfono-p-phenetidide
to:
N-{4-[2-(Methyl{2-[4-(methylsulfonamido)phenoxy]ethyl}amino)ethyl]phenyl}methanesulfonamide
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
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
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
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.
DOXYCYCLINE HYCLATE IMPURITIES/Organic Impurities USPNF Online Online 1-Jun-2022 NA NA In Table 2, footnote b: Change
(4S,4aR,5S,5aR,6R,12aS)-2-Acetyl-4-(dimethylamino)-4a,5a,6,12a-tetrahydro-3,5,10,12,12a-pentahydroxy-6-methyl-tetracene-1,11-dioxo-2-naphthacenecarboxamide.
to:
(4S,4aR,5S,5a… Read More
METHSUXIMIDE IMPURITIES/Organic Impurities USPNF Online Online 1-Sep-2022 NA NA In System suitability/Column efficiency: Change
NTL 5800 theoretical plates
to:
NLT 5800 theoretical plates
PRIMIDONE TABLETS ASSAY/Procedure USPNF Online Online 1-Dec-2022 NA NA In Sample solution: Change
0.05 mg/mL of primidone from the Standard stock solution in Diluent
to:
0.05 mg/mL of primidone from the Sample stock solution in Diluent
CHLOROPROCAINE HYDROCHLORIDE INJECTION ASSAY/Procedure USPNF Online Online 1-Feb-2023 NA NA In Sample solution: Change
Transfer about 100 mg of chloroprocaine hydrochloride to a 100-mL volumetric flask, dissolve in 40 mL of methanol, and dilute with water to volume.
to:
Transfer a volume of Injection, equivalent to about 100 mg of… Read More
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Apr-2023 NA NA Change
USP 2-Methylbenzhydrol RS
to:
USP Methylbenzhydrol RS
TIOCONAZOLE ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Jul-2023 NA NA In USP Tioconazole Related Compound A RS: Change
389.73
to:
389.72
AND
In USP Tioconazole Related Compound B RS: Change
458.62
to:
458.60
AND
In USP Tioconazole Related Compound C RS: Change
C16H13BrCl2… Read More
ZIPRASIDONE CAPSULES IMPURITIES USPNF Online Online 1-Sep-2023 NA NA In Organic Impurities/Solution B: Change
potassium hydroxide
to:
potassium hydroxide solution
AND
In Organic Impurities/Analysis: Change
449.40
to:
449.39
CEFDINIR IMPURITIES USPNF Online Online 1-Dec-2023 NA NA In Organic Impurities/Table 2/footnote a: Change
1N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine.
to:
N-[(Z)-2-(2-Aminothiazol-4-yl)-2-(hydroxyimino)acetyl]glycine.
MAGNESIUM OXIDE IMPURITIES/Limit of Calcium USPNF Online Online 1-Dec-2022 NA NA In Analysis: Change
CU = concentration of Magnesium Hydroxide in the Sample solution (mg/mL)
to:
CU = concentration of Magnesium Oxide in the Sample solution (mg/mL)
DOXYCYCLINE HYCLATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Jun-2022 NA NA In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
480.13
to:
480.90
ENZACAMENE ASSAY/Procedure USPNF Online Online 1-Dec-2022 NA NA In Analysis: Change
CU = concentration of enzacamene in the Sample solution (mg/mL)
to:
CU = concentration of Enzacamene in the Sample solution (mg/mL)
POTASSIUM GLUCONATE ORAL SOLUTION SPECIFIC TESTS USPNF Online Online 1-Feb-2023 NA NA Change
Alcohol Determination 〈611〉, Method II—Distillation Method:
to:
Alcohol Determination 〈611〉, Method I—Distillation Method:
ROSEMARY COMPOSITION/Content of Phenolic Diterpenes USPNF Online Online 1-May-2023 NA NA In Sample solution: Change
Before injection, pass through a membrane filter of 0.45-µL or finer pore size,
to:
Before injection, pass through a membrane filter of 0.45-µm or finer pore size,
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Jul-2023 NA NA Change
USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS (USP Methacrylic Acid Copolymer, Type C RS)
to:
USP Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) RS (USP Methacrylic Acid Copolymer Type C RS)
ZIPRASIDONE HYDROCHLORIDE IMPURITIES USPNF Online Online 1-Sep-2023 NA NA In Organic Impurities/Solution B: Change
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide TS to a pH of 6.0.
to:
Acetonitrile, methanol, and Buffer (55:5:40). Adjust with potassium hydroxide solution… Read More
CEFDINIR ADDITIONAL REQUIREMENTS USPNF Online Online 1-Dec-2023 NA NA In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42