Tetracycline Boluses
» Tetracycline Boluses contain the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of tetracycline hydrochloride (C22H24N2O8·HCl).
Packaging and storage— Preserve in tight containers.
Labeling— Label Boluses to indicate that they are intended for veterinary use only.
Identification— Shake a suitable quantity of finely powdered Boluses with methanol to obtain a solution containing the equivalent of 1 mg of tetracycline hydrochloride per mL, and filter. Using the filtrate as the Test Solution, proceed as directed under Identification—Tetracyclines 193.
Uniformity of dosage units 905: meet the requirements for Weight Variation.
Loss on drying 731 Dry about 100 mg of finely powdered Boluses, 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, or where the Boluses have a diameter of greater than 15 mm, it loses not more than 6.0% of its weight.
Assay— Transfer not less than 2 Boluses 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, using an accurately measured volume of this solution diluted quantitatively and stepwise with water to obtain 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 3694