Methacycline Hydrochloride Capsules
»Methacycline Hydrochloride Capsules contain the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of methacycline (C22H22N2O8).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing the equivalent of about 1mg of methacycline per mL,and filter.Using the filtrate as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 60minutes.
Procedure— Determine the amount of C22H22N2O8·HCl dissolved from UVabsorbances at the wavelength of maximum absorbance at about 345nm of filtered portions of the solution under test,suitably diluted with water,in comparison with a Standard solution having a known concentration of USP Methacycline Hydrochloride RSin the same Medium.
Tolerances— Not less than 70%(Q)of the labeled amount of C22H22N2O8·HCl is dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 7.5%.
Assay—
Mobile phase,System suitability preparation,andChromatographic system— Proceed as directed in the Assayunder Methacycline Hydrochloride.
Standard preparation— Transfer about 28mg of USP Methacycline Hydrochloride RS,accurately weighed,to a 50-mLvolumetric flask,add 10mLof water,dilute with Mobile phaseto volume,and mix.
Assay preparation— Place no fewer than 5Capsules in a high-speed,glass blender jar containing an accurately measured volume of water,and blend for 3to 5minutes to obtain a stock solution having a concentration of about 2.5mg of methacycline (C22H22N2O8)per mL.Filter,transfer 10.0mLof the filtrate to a 50-mLvolumetric flask,add 10mLof water,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed in the Assayunder Methacycline Hydrochloride.Calculate the quantity,in mg,of methacycline (C22H22N2O8)in each Capsule taken by the formula:
5(CE/1000)(V/N)(rU/rS),
in which Vis the volume,in mL,of water used to prepare the stock solution for the Assay preparation;Nis the number of Capsules taken to prepare the stock solution for the Assay preparation;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1233
Phone Number:1-301-816-8335
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