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PDF CSV February 7, 2021 through February 7, 2023 See 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 Target Online Fix Publication Description
ISOBUTYL ALCOHOL ASSAY/Procedure USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
rS = sum of all the peaks except those each of which with an area less than 0.1 times the area of the major peak from the Reference solution
to:
rT = sum of all the peaks except… Read More
FLUTICASONE PROPIONATE NASAL SPRAY IMPURITIES/Organic Impurities USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
Samples: System suitability solution, Identification solution, and Sample solution
to:
Samples: Identification solution and Sample solution
MESO-ZEAXANTHIN PREPARATION COMPOSITION/Stereoisomeric Composition USPNF Online Online 1-Feb-2023 NA NA In System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.… Read More
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.
<251> LEAD PROCEDURES/Procedure 1: Chemical Method USPNF Online Online 1-Jun-2023 NA NA In Analysis: Change
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonia cyanide solution,
to:
Add to the acid solution 5.0 mL of Standard dithizone solution and 4 mL of Ammonium… Read More
METARAMINOL BITARTRATE SPECIFIC TESTS/Content of Tartaric Acid USPNF Online Online 1-Feb-2023 NA NA In Analysis: Change
Result = {[(VSVB) × N × F]/2 × W} × 100
to:
Result = {[(VSVB) × N × F]/(2 × W)} × 100
MESO-ZEAXANTHIN IDENTIFICATION/C. USPNF Online Online 1-Jun-2023 NA NA Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
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
POLYETHYLENE GLYCOL STANDARDS WITH MOLECULAR WEIGHTS OF 1000, 2000, 3000, 4000, AND 6000 DALTONS (G/MOL) CHEMICAL INFORMATION USPNF Online Online 1-Feb-2023 NA NA Change
CAS RN®: 25332-68-3.
to:
CAS RN®: 25322-68-3.
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 Read More
MESO-ZEAXANTHIN PREPARATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Feb-2023 NA NA In USP meso-Zeaxanthin RS: Change
(3R,3′S-meso)-Zeaxanthin.
to:
(3R,3′S)-Zeaxanthin.
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
<251> LEAD REQUIREMENTS FOR PROCEDURE VALIDATION USPNF Online Online 1-Jun-2023 NA NA Change
• Precision Repeatability
to:
• Precision
METARAMINOL BITARTRATE ADDITIONAL REQUIREMENTS/USP Reference Standards 〈11〉 USPNF Online Online 1-Feb-2023 NA NA In USP Metaraminol Enantiomer RS: Change
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol.
C9H13NO2 167.21
to:
3-[(1S,2R)-2-Amino-1-hydroxypropyl]phenol D-tartrate.
C9… Read More
MESO-ZEAXANTHIN PREPARATION IDENTIFICATION/C. USPNF Online Online 1-Feb-2023 NA NA Change
(3R,3′S-meso)-zeaxanthin
to:
(3R,3′S)-zeaxanthin
MESO-ZEAXANTHIN COMPOSITION/Stereoisomeric Composition USPNF Online Online 1-Jun-2023 NA NA In System suitability: Change
[Note—The approximate relative retention times for (3S,3′S)-zeaxanthin, (3R,3′S-meso)-zeaxanthin, (3R,3′R)-zeaxanthin, and (3R,3′R,6′R)-lutein are 0.… Read More
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:
Methyl Acetate CHEMICAL INFORMATION USPNF Online Online 1-Feb-2023 NA NA Change
CAS RN®: 74-20-9.
to:
CAS RN®: 79-20-9.
MESO-ZEAXANTHIN CHEMICAL INFORMATION USPNF Online Online 1-Jun-2023 NA NA Change
(3R,3′S-meso)-Zeaxanthin
to:
(3R,3′S)-Zeaxanthin
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
PALONOSETRON HYDROCHLORIDE IMPURITIES USPNF Online Online 1-Jan-2023 NA NA In Limit of Unspecified Impurities: Change
Mobile phase and Chromatographic system: Proceed as directed in the Assay.
to:
Mobile phase, Standard stock solution, and Chromatographic system:… Read More
LYSINE ACETATE IMPURITIES/Related Compounds USPNF Online Online 1-Jun-2023 NA NA In Chromatographic system/Spray reagent: Change
0.2 g of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
to:
2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
METOLAZONE TABLETS ASSAY/Procedure USPNF Online Online 1-Jan-2023 NA NA In Buffer: Change
1.38 g of monobasic potassium phosphate monohydrate in 900 mL of water.
to:
1.38 g of monobasic sodium phosphate in 900 mL of water.
MAFENIDE ACETATE FOR TOPICAL SOLUTION IMPURITIES/Organic Impurities USPNF Online Online 1-Jan-2023 NA NA In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
Read More
LYSINE HYDROCHLORIDE IMPURITIES/Related Compounds USPNF Online Online 1-Jun-2023 NA NA In Chromatographic system/Spray reagent: Change
0.2 g of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
to:
2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
ZINC UNDECYLENATE ASSAY/Procedure USPNF Online Online 1-Dec-2022 NA NA In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows… Read More
PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE SUSPENSION IDENTIFICATION USPNF Online Online 1-Dec-2022 NA NA In Test A: Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension: the spot obtained from the test solution, corresponding in RF value to that obtained from the Standard solution, is… Read More
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS PERFORMANCE TESTS/Dissolution <711> USPNF Online Online 1-Dec-2022 NA NA In Test 6: Change
Times: 0.5, 1, and 4 h—for strengths 540 and 1080 mg as potassium citrate monohydrate; 0.5, 1, and 6 h—for strength 1620 mg as potassium citrate monohydrate.
to:
Times: 0.5, 1, and 4 h—for strength 540 mg as… Read More
ROCURONIUM BROMIDE IMPURITIES/Organic Impurities USPNF Online Online 1-Dec-2022 NA USPNF 2023 Issue 3 In footnote b of Table 1: Change
2β-(Morpholin-4-yl)-16β-(pyrrolidin-1-yl)-5α-androstan-3α,17β-diol.
to:
2β-(Morpholin-4-yl)-16β-(pyrrolidin-1-yl)-5α-androstane-3α,17β-diol.
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 = (r… Read More
MOMETASONE FUROATE TOPICAL SOLUTION IDENTIFICATION USPNF Online Online 1-Dec-2022 NA NA In test A: Change
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay.
to:
The retention time of the… Read More
FELODIPINE IMPURITIES/Organic Impurities USPNF Online Online 1-Dec-2022 NA NA Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase… Read More
PENICILLIN G BENZATHINE INJECTABLE SUSPENSION IDENTIFICATION USPNF Online Online 1-Dec-2022 NA NA Change
It responds to the Identification test under Penicillin G Benzathine Oral Suspension.
to:
Mix a portion of it with methanol to obtain a solution containing about 3000 Penicillin G Units per mL. Apply 20 µL of this test… Read More
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
ROCURONIUM BROMIDE CHEMICAL INFORMATION USPNF Online Online 1-Dec-2022 NA USPNF 2023 Issue 3 Change
609.68
to:
609.69
DOXAZOSIN MESYLATE IMPURITIES/Organic Impurities USPNF Online Online 1-Nov-2022 NA NA In Analysis: Change
CS = concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)
to:
CS… Read More
CALCIUM L-5-METHYLTETRAHYDROFOLATE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USPNF Online Online 1-Nov-2022 NA NA Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
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)
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)
NALOXONE HYDROCHLORIDE IMPURITIES USPNF Online Online 1-Dec-2022 NA NA In Limit of Naloxone Related Compound D: Delete
Sensitivity solution: 1.25 µg/mL of USP Naloxone Related Compound D RS in 0.1 N hydrochloric acid
AND
In System suitability/Samples: Delete
Sensitivity… Read More
CALCIUM L-5-METHYLTETRAHYDROFOLATE IMPURITIES/Related Compounds USPNF Online Online 1-Nov-2022 NA NA In Analysis: Change
CS = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
CS = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in… Read More
SITAGLIPTIN PHOSPHATE CHEMICAL INFORMATION USPNF Online Online 1-Nov-2022 NA NA Change
523.32
to:
523.33
AND
Change
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate
to:
(3R)-3-Amino-1-[3-(… 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
CALCIUM UNDECYLENATE ASSAY/Procedure USPNF Online Online 1-Nov-2022 NA NA In Solution A: Change
0.15 N hydrochloric acid in water prepared as follows. Transfer 150 mL of hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.
to:
0.15 N hydrochloric acid in water prepared as follows… Read More
CALCIUM L-5-METHYLTETRAHYDROFOLATE IDENTIFICATION USPNF Online Online 1-Nov-2022 NA NA In A. Spectroscopic Identification Tests <197>, Infrared Spectroscopy: 197K: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
TETRACYCLINE HYDROCHLORIDE SPECIFIC TESTS/Bacterial Endotoxins Test <85> USPNF Online Online 1-Nov-2022 NA NA Change
Where the label states tetracycline hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in… Read More
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)
DIAZOXIDE IMPURITIES/Organic Impurities USPNF Online Online 1-Nov-2022 NA NA In footnote a in Table 2: Change
7-Chloro-2H-benzothiadiazin-3(4H)-one 1,1-dioxide.
to:
7-Chloro-2H-1,2,4-benzothiadiazin-3(4H)-one 1,1-dioxide.
CALCIUM L-5-METHYLTETRAHYDROFOLATE IMPURITIES/Enantiomeric Purity USPNF Online Online 1-Nov-2022 NA NA In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
DOXORUBICIN HYDROCHLORIDE FOR 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)