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Minocycline Hydrochloride Tablets
» Minocycline Hydrochloride Tablets 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.
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.
Dissolution 711—
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 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%.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Minocycline Hydrochloride.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of minocycline (C23H27N3O7), to a 100-mL volumetric flask, add about 50 mL of water, and shake for about 1 minute. 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 C23H27N3O7 in the portion of Tablets taken by the formula:
0.1C(rU / rS).
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1441
Phone Number : 1-301-816-8223