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 á11ñ— 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 0.5mg of chlortetracycline hydrochloride per mL,and filter.Using the filtrate so obtained as the Test solution,and a methanol solution containing in each mL0.5mg of USP Chlortetracycline Hydrochloride RS,0.5mg of USP Oxytetracycline RS,and 0.5mg of USP Tetracycline Hydrochloride RSas the Resolution solution,proceed as directed for Method IIunder Identification—Tetracyclines á193ñ.

Disintegration á701ñ: 1hour,simulated gastric fluid TSbeing used as the test medium in place of water.

Uniformity of dosage units á905ñ: meet the requirements for Weight Variation.

Water,Method Iá921ñ: not more than 3.0%,or where the Tablets have a diameter of greater than 15mm,not more than 6.0%,a quantity of finely ground Tablet powder,accurately weighed,being used.

Assay— Transfer not less than 5Tablets to a high-speed glass blender jar containing an accurately measured volume of 0.01Nhydrochloric acid,so that after blending for 3to 5minutes a solution of convenient concentration is obtained.Proceed as directed for chlortetracycline under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this solution diluted quantitatively and stepwise with water to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.

Expert Committee:(VET)Veterinary Drugs

USP28–NF23Page 460

Phone Number:1-301-816-8178