Errata - English

In Analysis: Change
Results = (A_U/A_S) × C_S × D × (1/L) × V × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
D = dilution factor for Sample solution, if needed
L = label claim (mg/Tablet)
V = volume of Medium, 500 mL
to:
Result = (A_U/A_S) × C_S × V × D × (M_r1/M_r2) × (1/L) × 100
A_U = absorbance of the Sample solution
A_S = absorbance of the Standard solution
C_S = concentration of USP Prochlorperazine Maleate RS in the Standard solution
V = volume of Medium, 500 mL
D = dilution factor for the Sample solution, if needed
M_r1 = molecular weight of prochlorperazine, 373.94
M_r2 = molecular weight of prochlorperazine maleate, 606.09
L = label claim (mg/Tablet)

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

Change
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution
to:
System suitability solution: 5 µg/mL each of USP Promethazine Hydrochloride RS and USP Promethazine Related Compound B RS from the Standard stock solution and System suitability stock solution, respectively, in Diluent
Standard solution: 5 µg/mL of USP Promethazine Hydrochloride RS from the Standard stock solution in Diluent
Sensitivity solution: 0.25 µg/mL of USP Promethazine Hydrochloride RS from the Standard solution in Diluent

In Standardization with visual end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄
AND
In Standardization with potentiometric end point: Change
M = mL edetate disodium × edetate disodium/mL ZnSO₄
to:
M = mL edetate disodium × M edetate disodium/mL ZnSO₄

In USP Econazole Related Compound C RS: Change
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium nitrate (salt).
C₂₅H₂₁Cl₁₄N₃O₄ 569.26
to:
1-(4-Chlorobenzyl)-3-{2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazol-3-ium chloride.
C₂₅H₂₁Cl₅N₂O 542.71

In Analysis: Change
Calculate the percentage of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P × 100
to:
Calculate the quantity, in µg/mg, of ceftiofur (C₁₉H₁₇N₅O₇S₃) in the portion of Ceftiofur Hydrochloride taken:
Result = (r_U/r_S) × (C_S/C_U) × P

In System suitability solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Standard solution: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In System suitability/Samples: Change
USP Calcium DL-5-Methyltetrahydrofolate RS
to:
USP Calcium D,L-5-Methyltetrahydrofolate RS
AND
In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

In Analysis: Change
C_S = concentration of USP Calcium DL-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)
to:
C_S = concentration of USP Calcium D,L-5-Methyltetrahydrofolate RS in the Standard solution (mg/mL)

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 which tetracycline hydrochloride is used can be met.
to:
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 which Tetracycline Hydrochloride is used can be met.

Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

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-(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

In Analysis: Change
C_S = 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:
C_S = concentration of the corresponding USP Reference Standard or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

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. Transfer 150 mL of 0.5 N hydrochloric acid VS to a 500-mL volumetric flask, dilute with water to volume, and mix well.

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 solution,
AND
In System suitability/Suitability requirements: Delete
Signal-to-noise ratio: NLT 10, Sensitivity solution

Change
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.
to:
Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay, and use 40 µL injection volume for the Sensitivity solution.

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. Transfer 150 mL of 0.5 N hydrochloric acid to a 500-mL volumetric flask, dilute with water to volume, and mix well.

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_U/r_S) × (C_S/C_U) × D × 100
to:
Result = (r_U/r_S) × (C_S/C_U) × 100
AND
Delete
D = dilution factor for the Sample solution, 2.5

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 potassium citrate monohydrate; 0.5, 1, and 6 h—for strengths 1080 and 1620 mg as potassium citrate monohydrate.

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 solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in R_F value to that obtained from the Standard solution.

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 R_F value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.
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 solution and 20 µL of a Standard solution of USP Penicillin G Benzathine RS in methanol containing 2.5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 〈621〉) coated with a 0.25-mm layer of chromatographic silica gel, and allow the spots to dry. Using an unlined developing chamber, develop the chromatogram in a solvent system consisting of a mixture of methanol, acetonitrile, and ammonium hydroxide (70:30:3) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and allow to air-dry. Spray the plate uniformly with a spray reagent prepared as follows. Dissolve 20 g of tartaric acid and 1.7 g of bismuth subnitrate in 80 mL of water. Add 2.5 mL of this solution, 2.5 mL of potassium iodide solution (4 in 10), and 10 g of tartaric acid to 50 mL of water, and mix. Examine the chromatograms: the principal spot obtained from the test solution corresponds in R_F value to that obtained from the Standard solution. The spot obtained from the test solution, corresponding in R_F value to that obtained from the Standard solution, is completely resolved from a second spot, produced by penicillin G procaine.

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 major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

In System suitability: Change
Samples: System suitability solution, Standard solution A, and Standard solution B
to:
Samples: System suitability solution and Standard solution A
AND
In Analysis: Change
Samples: Mobile phase, Standard solution A, and Sample solution
Chromatograph the Standard solution and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.
to:
Samples: Mobile phase, Standard solution A, Standard solution B, and Sample solution
Chromatograph Standard solution B and adjust the integration parameters so that the response is 5%–15% of full-scale deflection.

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: Proceed as directed in the Assay.