Packaging and storage— Preserve in tight containers, protected from light.

Labeling— Label the Tablets to indicate that they are intended for veterinary use only.

USP Reference standards 11— USP Chlortetracycline Hydrochloride RS. USP Oxytetracycline RS. USP Tetracycline Hydrochloride RS.

Identification— Shake a suitable quantity of finely ground Tablet powder with methanol to obtain a solution containing about 0.5 mg of chlortetracycline hydrochloride per mL, and filter. Using the filtrate so obtained as the Test solution, and a methanol solution containing in each mL 0.5 mg of USP Chlortetracycline Hydrochloride RS, 0.5 mg of USP Oxytetracycline RS, and 0.5 mg of USP Tetracycline Hydrochloride RS as the Resolution solution, proceed as directed for Method II under Identification—Tetracyclines 193.

Disintegration 701: 1 hour, simulated gastric fluid TS being used as the test medium in place of water.

Uniformity of dosage units 905: meet the requirements for Weight Variation.

Water, Method I 921: not more than 3.0%, or where the Tablets have a diameter of greater than 15 mm, not more than 6.0%, a quantity of finely ground Tablet powder, accurately weighed, being used.

Residual solvents 467: meet the requirements.

Assay— Transfer not less than 5 Tablets to a high-speed glass blender jar containing an accurately measured volume of 0.01 N hydrochloric acid, so that after blending for 3 to 5 minutes a solution of convenient concentration is obtained. Proceed as directed for chlortetracycline 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.

Expert Committee : (VET05) Veterinary Drugs 05

USP29–NF24 Page 499

Phone Number : 1-301-816-8178