Oxytetracycline Hydrochloride Capsules
»Oxytetracycline Hydrochloride Capsules contain the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of oxytetracycline (C22H24N2O9).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing 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: water;900mL.
Apparatus 2: 75rpm.
Time: 60minutes.
Procedure— Determine the amount of C22H24N2O9dissolved from UVabsorbances at the wavelength of maximum absorbance at about 273nm of filtered portions of the solution under test,suitably diluted with water,in comparison with a Standard solution having a known concentration of USP Oxytetracycline RSin the same medium,using 5mLof 0.1Nhydrochloric acid to dissolve the Standard.
Tolerances— Not less than 80%(Q)of the labeled amount of C22H24N2O9is dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
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 5.0%of its weight.
Assay—
Tetrabutylammonium hydrogen sulfate solution ,Edetate disodium solution,pH7.5Phosphate buffer,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system—Proceed as directed in the Assayunder Oxytetracycline.
Assay preparation— Remove,as completely as possible,the contents of not less than 20Capsules,and mix.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of oxytetracycline,to a 500-mLvolumetric flask,add about 50mLof 0.01Nhydrochloric acid,and swirl to dissolve.Dilute with 0.01Nhydrochloric acid to volume,mix,and filter a portion of the solution through a 0.5-µm or finer porosity filter.Use the filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Oxytetracycline.Calculate the quantity,in mg,of oxytetracycline (C22H24N2O9)in the portion of Capsules taken by the formula:
0.5(CP)(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1451
Phone Number:1-301-816-8335