Oxytetracycline Tablets
» Oxytetracycline Tablets contain the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C22H24N2O9.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— Shake a suitable quantity of finely powdered Tablets with methanol to obtain a solution containing about 1 mg of oxytetracycline per mL, and filter. Using the filtrate as the Test Solution, proceed as directed for Method II under Identification—Tetracyclines 193.
Dissolution 711
Medium: 0.1 N hydrochloric acid; 900 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C22H24N2O9 dissolved from UV absorbances at the wavelength of maximum absorbance at about 353 nm 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 RS in the same medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C22H24N2O9 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 7.5%.
Tetrabutylammonium hydrogen sulfate solution, Edetate disodium solution, pH 7.5 Phosphate buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Oxytetracycline.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of oxytetracycline, to a 500-mL volumetric flask, add about 25 mL of 0.01 N hydrochloric acid, and mix. Dilute with 0.01 N hydrochloric acid to volume, and mix. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay under Oxytetracycline. Calculate the quantity, in mg, of C22H24N2O9 in the portion of Tablets taken by the formula:
0.5(CP)(rU / rS)
in which C is the concentration, in mg per mL, of USP Oxytetracycline RS in the Standard preparation, and the other terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3179
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.