Errata - English

Line 2 of USP Levofloxacin Related Compound A RS: Change
(S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid.
to:
(S)-9-Fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid.
AND
Line 2 of USP Levofloxacin Related Compound B RS: Change
(S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4-benzoxazine-6-carbocylic acid.
to:
(S)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid.

Footnote d: Change
((5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(1-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.
to:
(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-((2´-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H-imidazole-5-carboxylate.

Footnote c: Change
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-1-ene hydrochloride (identified and reported as an individual unspecified impurity if present).
to:
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-6-ene hydrochloride (identified and reported as an individual unspecified impurity if present).
AND
Footnote d: Change
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-6-ene hydrochloride (identified and reported as an individual unspecified impurity if present).
to:
1-(3-Methoxyphenyl)-2-(dimethylaminomethyl) cyclohex-1-ene hydrochloride (identified and reported as an individual unspecified impurity if present).

Line 2 of Venlafaxine Related Compound A RS: Change
1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol.
C₁₆H₂₅NO₂
263.38
to:
1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride.
C₁₆H₂₅NO₂ · HCl
299.84

Line 2 of Venlafaxine Related Compound A RS: Change
1-(1-(4-methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol.
C₁₆H₂₅NO₂
263.38
to:
1-(1-(4-Methoxyphenyl)-2-(methylamino)ethyl)cyclohexanol hydrochloride.
C₁₆H₂₅NO₂ · HCl
299.84

Line 11 of Analysis: Change
Result = (R_U/R_S) × (C_S/C_U) × D × F × 100
to:
Result = (R_U/R_S) × (C_S/C_U) × D × F
AND
Line 18 of Analysis: Change
C_S = percentage of methanol in the Standard solution (% v/v)
to:
C_S = percentage of methanol in the Standard solution
AND
Line 23 of Analysis: Change
F = conversion factor, 0.001 g/mg
to:
F = conversion factor, 1000 mg/g

Line 1: Change
It meets the requirements of the test for Chromatographic purity under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Test solution.
to:
It meets the requirements of the test for Organic Impurities under Albuterol, except to read Albuterol Sulfate in place of Albuterol and to use water instead of methanol as the solvent to prepare the Standard solution and the Sample solution.

Line 2: Change
Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate for analysis.
to:
Sample stock solution: Nominally 0.1 mg/mL of amitriptyline hydrochloride in methanol from a suitable amount of finely powdered Tablets. Filter a portion of the solution, and use the filtrate.
Sample solution: Nominally 0.01 mg/mL of amitriptyline hydrochloride from Sample stock solution in methanol

Line 2: Change
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
to:
Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C₂₃H₂₇N₃O₇) per mL. Use this solution within 3 hours.
Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride.
to:
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 2: Change
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
to:
Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer porosity. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C₂₃H₂₇N₃O₇) per mL. Use this solution within 3 hours.
Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride.
to:
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 2: Change
Mobile phase and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
to:
Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride.
to:
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 2: Change
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Proceed as directed in the Assay under Minocycline Hydrochloride.
to:
Mobile phase—Prepare a mixture of 0.2 M ammonium oxalate, 0.01 M edetate disodium, dimethylformamide, and tetrahydrofuran (600:180:120:80). Adjust with ammonium hydroxide to a pH of 7.2, and pass through a filter of 0.5-µm or finer pore size. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Minocycline Hydrochloride RS in water to obtain a solution having a known concentration of about 500 µg of minocycline (C₂₃H₂₇N₃O₇) per mL. Use this solution within 3 hours.
Resolution solution—Transfer 10 mg of USP Minocycline Hydrochloride RS to a 25-mL volumetric flask, add 20 mL of 0.2 M ammonium oxalate, and swirl to dissolve. Heat on a water bath at 60° for 180 minutes, and allow to cool. Dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 280-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1, and is maintained at a constant temperature of about 40°. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the capacity factor, k´, is not less than 5.0 and not more than 11.5; the tailing factor for the analyte peak is not less than 0.9 and not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.7 for epiminocycline and 1.0 for minocycline; and the resolution, R, between epiminocycline and minocycline is not less than 4.6.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride.
to:
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Line 7 of Analysis: Change
R_U = internal standard ratio (peak response of oxycodone/peak response of ethylparaben) from the Standard solution
R_S = internal standard ratio (peak response of oxycodone/peak response of ethylparaben) from the Sample solution
to:
R_U = peak response ratio of oxycodone to ethylparaben from the Sample solution
R_S = peak response ratio of oxycodone to ethylparaben from the Standard solution

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 5: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 7 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation 1 or Assay preparation 2 instead of Sample solution.

Line 5: Change
Potassium stock solution—
to:
Standard stock solution—
AND
Line 7: Change
Prepare as directed for Standard preparations
to:
Prepare as directed for Standard solutions
AND
Line 7 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution.

Line 5: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
Line 1 of Procedure: Change
in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation 1 or Assay preparation 2 instead of Sample solution.

Line 2: Change
Potassium stock solution and Standard preparations—
to:
Standard stock solution and Standard solutions—
AND
Line 1 of Procedure: Change
for Procedure in the Assay under Potassium Chloride Oral Solution.
to:
for Instrumental conditions and Analysis in the Assay under Potassium Chloride Oral Solution, except use Assay preparation instead of Sample solution.

Line 11 of USP Tacrolimus System Suitability Mixture RS: Change
and tacrolimus 8-propyl analog
(3S,4R,5S,8S,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-propyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone.
to:
and tacrolimus 8-propyl analog
(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-{(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-8-pro-pyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21-(4H,23H)-tetrone.

Line 4 of Analysis: Change
Determine the alcohol content of the sample thus prepared by the Gas–Liquid Chromatographic Method (see Method II in Alcohol Determination <611>, using methyl ethyl ketone as the internal standard in place of acetone.
to:
Determine the alcohol content of the sample thus prepared by the Gas Chromatographic Method (see Method II in Alcohol Determination <611>), using methyl ethyl ketone as the internal standard in place of acetonitrile.