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.

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 2: Change
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride.
to:
Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL.
AND
After the Assay preparation subsection: Add
System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diphenhydramine Hydrochloride.
to:
Separately inject equal volumes, about 10 μL, of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

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.

Line 2: Change
Mobile phase, Standard preparation, System suitability solution, and Chromatographic system—Prepare as directed in the Assay under Diphenhydramine Hydrochloride.
to:
Mobile phase—Prepare a solution of acetonitrile, water, and triethylamine (50: 50: 0.5), adjust with glacial acetic acid to a pH of 6.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography <621> ).
Standard preparation—Dissolve an accurately weighed quantity of USP Diphenhydramine Hydrochloride RS in water to obtain a solution having a known concentration of about 0.5 mg per mL.
AND
After the Assay preparation subsection: Add
System suitability solution—Dissolve about 5 mg of benzophenone in 5 mL of acetonitrile, dilute with water to 100 mL, and mix. Transfer 1.0 mL of this solution and 5 mg of diphenhydramine hydrochloride to a 10-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L10. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure; the resolution, R, between the benzophenone and diphenhydramine peaks is not less than 2.0. Chromatograph replicate injections of the Standard preparation, and record the peak responses as directed for Procedure; the relative standard deviation is not more than 2.0%, and the tailing factor for the diphenhydramine hydrochloride peak is not more than 2.0.
AND
Line 1 of Procedure: Change
Proceed as directed for Procedure in the Assay under Diphenhydramine Hydrochloride.
to:
Separately inject equal volumes, about 10 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 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

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).

Change the subsection head
Buffer:
to:
Buffer A:
AND
After the Buffer A subsection: Add
Buffer B: 0.067 M dibasic potassium phosphate
AND
Line 1 of Mobile phase: Change
Methanol and Buffer
to:
Methanol and Buffer A
AND
Line 4 of Sample stock solution: Change
with the aid of 330 mL of Buffer, to a 1000-mL volumetric flask containing 50 mL of Buffer.
to:
with the aid of 330 mL of Buffer B, to a 1000-mL volumetric flask containing 50 mL of Buffer B.

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
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 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
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—
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 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 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 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 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