Errata - English

Row 13 of Column 1 of Table 2: Change
3-Epimer^m
to:
3R-Epimer^m
AND
Row 16 of Column 1 of Table 2: Change
5-Epimer^p
to:
5R-Epimer^p
AND
Row 17 of Column 1 of Table 2: Change
Valine urea analog^q
to:
Diacyl valine urea^q

Line 12 of Analysis: Change
C_S = concentration of 3,5-dimethylphenol or chloroxylenol related compound A in the Standard solution (mg/mL)
to:
C_S = concentration of 3,5-dimethylphenol or USP Chloroxylenol Related Compound A RS in the Standard solution (mg/mL)

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 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
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
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
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
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.

Footnote b: Change
cis isomer of the hydroxy compound.
to:
trans isomer of the hydroxy compound.
AND
Footnote c: Change
trans isomer of the hydroxy compound.
to:
cis isomer of the hydroxy compound.
AND
Footnote d: Change
cis isomer of the monoacrylate.
to:
trans isomer of the monoacrylate.
AND
Footnote e: Change
trans isomer of the monoacrylate.
to:
cis isomer of the monoacrylate.