Tetracycline Hydrochloride Soluble Powder
» Tetracycline Hydrochloride Soluble Powder contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C22H24N2O8·HCl.
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that it is intended for veterinary use only.
Identification— Shake a suitable quantity of Powder with methanol to obtain a solution containing the equivalent of 1 mg of tetracycline hydrochloride per mL, and filter. Using the filtrate so obtained as the Test Solution, proceed as directed under Identification—Tetracyclines 193.
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 2.0% of its weight.
Assay— Transfer an accurately weighed quantity of Powder to a high-speed blender jar containing an accurately measured volume of 0.1 N hydrochloric acid, so that the solution so obtained contains not less than 150 µg of tetracycline hydrochloride per mL, and blend for about 3 to 5 minutes. Proceed as directed for tetracycline under Antibiotics—Microbial Assays 81, diluting an accurately measured volume of this solution quantitatively and stepwise with water to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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 3698