Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Troleandomycin RS.

Identification— Suspend mixed Capsule contents, equivalent to about 200 mg of oleandomycin (C35H61NO12), in 20 mL of chloroform, allow to settle, and filter. Using the filtrate so obtained as the test solution, proceed as directed in Identification test B under Troleandomycin: the specified result is obtained.

Loss on drying 731— Dry about 100 mg, accurately weighed, of Capsule contents in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 5.0% of its weight.

Residual solvents 467: meet the requirements.

Assay— Place not less than 5 Capsules in a high-speed glass blender jar containing 500.0 mL of a mixture of isopropyl alcohol and water (4:1), and blend for 4 ± 1 minutes. Dilute this solution quantitatively with the same solvent to obtain a stock test solution containing the equivalent of about 1 mg of oleandomycin (C35H61NO12) per mL. Proceed as directed for troleandomycin under Antibiotics—Microbial Assays 81, using an accurately measured volume of this stock test solution diluted quantitatively with water to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 2221

Phone Number : 1-301-816-8223