Minocycline Hydrochloride Capsules
» Minocycline Hydrochloride Capsules contain the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of minocycline (C23H27N3O7).
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure Determine the amount of C23H27N3O7 dissolved from UV absorbances at the wavelength of maximum absorbance at about 348 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Minocycline Hydrochloride RS in the same medium.
Tolerances Not less than 75% (Q) of the labeled amount of C23H27N3O7 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 12.0%.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Minocycline Hydrochloride.
Assay preparation Weigh the contents of not less than 20 Capsules, and calculate the average weight per Capsule. Mix the combined contents of the Capsules, transfer an accurately weighed portion, equivalent to about 50 mg of minocycline (C23H27N3O7), to a 100-mL volumetric flask, add about 50 mL of water, and shake to dissolve. Dilute with water to volume, mix, and filter.
Procedure Proceed as directed for Procedure in the Assay under Minocycline Hydrochloride. Calculate the quantity, in mg, of minocycline (C23H27N3O7) in the portion of Capsules taken by the formula:
0.1C(rU / rS).
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USP35NF30 Page 3927