Tetracycline Hydrochloride and Nystatin Capsules, chemical structure, molecular formula, Reference Standards
Tetracycline Hydrochloride and Nystatin Capsules
»Tetracycline Hydrochloride and Nystatin Capsules contain not less than 90.0percent and not more than 125.0percent of the labeled amount of tetracycline hydrochloride (C22H24N2O8·HCl),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.
USP Reference standards á11ñ
USP Tetracycline Hydrochloride RS.USP Nystatin RS.
Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing about 1mg of tetracycline hydrochloride per mL,and filter.Using the filtrate as the Test Solution,proceed as directed under IdentificationTetracyclines á193ñ.
Determine the amount of tetracycline hydrochloride (C22H24N2O8·HCl)dissolved from UVabsorbances at the wavelength of maximum absorbance at about 276nm 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 Tetracycline Hydrochloride RSin the same Medium.
Not less than 70%(Q)of the labeled amount of C22H24N2O8·HCl is dissolved in 60minutes.
Loss on drying á731ñ
Dry about 100mg of Capsule contents,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 4.0%of its weight.
Limit of 4-epianhydrotetracycline á226ñ
To a quantity of Capsule contents,equivalent to about 250mg of tetracycline hydrochloride,add 10mLof 0.1Nhydrochloric acid,and adjust with 6Nammonium hydroxide to a pHof 7.8.Transfer this solution with the aid of EDTA Bufferto a 50-mLvolumetric flask,dilute with EDTA Bufferto volume,and mix.Use this solution,without delay,as the Test Solution:not more than 3.0%is found.
Assay for tetracycline hydrochloride
Proceed with Capsules as directed in the Assayunder Tetracycline Hydrochloride Capsules.
Assay for nystatin
Proceed as directed for Nystatin under AntibioticsMicrobial 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.
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
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