Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Troleandomycin RS.

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

Loss on drying á731ñ— Dry about 100mg,accurately weighed,of Capsule contents in a capillary-stoppered bottle in vacuum at 60for 3hours:it loses not more than 5.0%of its weight.

Assay— Place not less than 5Capsules in a high-speed glass blender jar containing 500.0mLof a mixture of isopropyl alcohol and water (4:1),and blend for 4±1minutes.Dilute this solution quantitatively with the same solvent to obtain a stock test solution containing the equivalent of about 1mg of oleandomycin (C35H61NO12)per mL.Proceed as directed for troleandomycin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this stock test solution diluted quantitatively with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1997

Phone Number:1-301-816-8335