Minocycline Hydrochloride Capsules
»Minocycline Hydrochloride Capsules contain the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of minocycline (C23H27N3O7).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of C23H27N3O7dissolved from UVabsorbances at the wavelength of maximum absorbance at about 348nm 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 RSin the same medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C23H27N3O7is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 12.0%.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Minocycline Hydrochloride.
Assay preparation— Weigh the contents of not less than 20Capsules,and calculate the average weight per Capsule.Mix the combined contents of the Capsules,transfer an accurately weighed portion,equivalent to about 50mg of minocycline (C23H27N3O7),to a 100-mLvolumetric flask,add about 50mLof water,and shake to dissolve.Dilute with water to volume,mix,and filter.
Procedure— Proceed as directed for Procedurein the Assayunder Minocycline Hydrochloride.Calculate the quantity,in mg,of minocycline (C23H27N3O7)in the portion of Capsules taken by the formula:
0.1C(rU/rS).
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1299
Phone Number:1-301-816-8335