Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards 11— USP Tetracycline Hydrochloride RS. USP Nystatin RS.

Identification— Shake a suitable quantity of Capsule contents with methanol to obtain a solution containing about 1 mg of tetracycline hydrochloride per mL, and filter. Using the filtrate as the Test Solution, proceed as directed under Identification—Tetracyclines 193.

Dissolution 711—

Loss on drying 731— Dry about 100 mg of Capsule contents, 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 4.0% of its weight.

Limit of 4-epianhydrotetracycline 226— To a quantity of Capsule contents, equivalent to about 250 mg of tetracycline hydrochloride, add 10 mL of 0.1 N hydrochloric acid, and adjust with 6 N ammonium hydroxide to a pH of 7.8. Transfer this solution with the aid of EDTA Buffer to a 50-mL volumetric flask, dilute with EDTA Buffer to volume, and mix. Use this solution, without delay, as the Test Solution: not more than 3.0% is found.

Residual solvents 467: meet the requirements.

Assay for tetracycline hydrochloride— Proceed with Capsules as directed in the Assay under Tetracycline Hydrochloride Capsules.

Assay for nystatin— Proceed as directed for Nystatin under Antibiotics—Microbial Assays 81, blending not less than 5 Capsules for 3 to 5 minutes in a high-speed blender with a sufficient, accurately measured, volume of dimethylformamide to obtain a solution of convenient concentration. Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400 USP Nystatin Units per mL. Dilute this stock solution quantitatively with Buffer No. 6 to obtain a Test Dilution having a concentration of nystatin assumed to be equal to the median dose level of the Standard.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 2105

Phone Number : 1-301-816-8223