Minocycline Hydrochloride Tablets
»Minocycline Hydrochloride Tablets 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 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,andChromatographic system— Proceed as directed in the Assayunder Minocycline Hydrochloride.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 50mg of minocycline (C23H27N3O7),to a 100-mLvolumetric flask,add about 50mLof water,and shake for about 1minute.Dilute with water to volume,mix,and filter.
Procedure— Proceed as directed for Procedurein the Assayunder Minocycline Hydrochloride.Calculate the quantity,in mg,of C23H27N3O7in the portion of Tablets 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 1300
Phone Number:1-301-816-8335
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