Oxytetracycline and Nystatin Capsules
»Oxytetracycline and Nystatin Capsules contain not less than 90.0percent and not more than 120.0percent of the labeled amount of oxytetracycline (C22H24N2O9),and not less than 90.0percent and not more than 135.0percent of the labeled amount of USP Nystatin Units.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing about 1mg of oxytetracycline per mL,and filter.Using the filtrate as the Test Solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.
Dissolution á711ñ—
Medium: 0.1Nhydrochloric acid;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of oxytetracycline (C22H24N2O9)dissolved from UVabsorbances at the wavelength of maximum absorbance at about 353nm 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 Oxytetracycline RSin the same medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C22H24N2O9is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements for Weight Variationwith respect to oxytetracycline.
Water,Method Iá921ñ: not more than 7.5%.
Assay for oxytetracycline— Place not less than 5Capsules in a high-speed glass blender jar containing an accurately measured volume of 0.1Nhydrochloric acid,and blend for 3to 5minutes,so that the stock solution so obtained contains not less than 150µg of oxytetracycline (C22H24N2O9)per mL.Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this stock solution diluted quantitatively and stepwise with water to yield a Test Dilutionhaving a concentration of oxytetracycline assumed to be equal to the median dose level of the Standard.
Assay for nystatin— Proceed as directed for Nystatin under Antibiotics—Microbial Assays á81ñ,blending not less than 5Capsules for 3to 5minutes in a high-speed blender with a sufficient accurately measured volume of dimethylformamide to obtain a solution of convenient concentration.Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400USP Nystatin Units per mL.Dilute this stock solution quantitatively with Buffer No.6to obtain a Test Dilutionhaving a concentration of nystatin assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1449
Phone Number:1-301-816-8335
Return