Oxytetracycline Hydrochloride Soluble Powder
» Oxytetracycline Hydrochloride Soluble Powder is a dry mixture of Oxytetracycline Hydrochloride and one or more suitable excipients. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of oxytetracycline hydrochloride (C22 H24N2O9·HCl).
Packaging and storage— Preserve in well-closed containers.
Labeling— Label it to indicate that it is for oral veterinary use only.
A: Shake a quantity of Soluble Powder with methanol to obtain a solution containing about 1 mg of oxytetracycline hydrochloride per mL. Filter if necessary to obtain a clear solution. Using the filtrate as the Test solution, proceed as directed for Method II under Identification—Tetracyclines 193.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
pH 791: between 1.5 and 3.0, in the solution obtained as directed in the labeling.
Loss on drying 731 Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 3.0% of its weight.
Minimum fill 755: meets the requirements.
Tetrabutylammonium hydrogen sulfate solution, Edetate disodium solution, pH 7.5 Phosphate buffer, Mobile phase, Standard preparation, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Oxytetracycline.
Assay preparation— Transfer an accurately weighed portion of the Soluble Powder, equivalent to about 100 mg of oxytetracycline hydrochloride, to a 500-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix. Pass a portion of this solution through a filter having a 0.5-µm or finer porosity. Use the filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay under Oxytetracycline. Calculate the quantity, in g, of oxytetracycline hydrochloride (C22H24N2O9·HCl) in each g of Soluble Powder taken by the formula:
0.5(496.90 / 460.44)(CP / W)(rU / rS)
in which 496.90 and 460.44 are the molecular weights of oxytetracycline hydrochloride and oxytetracycline, respectively; C is the concentration, in mg per mL, of USP Oxytetracycline RS in the Standard preparation; P is the assigned potency, in µg of oxytetracycline per mg, of USP Oxytetracycline RS; W is the weight, in g, of Soluble Powder taken to prepare the Assay preparation; and rU and rS are the oxytetracycline peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals
(VET05) Veterinary Drugs 05
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3182
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.