Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Paromomycin Sulfate RS.

Identification— Mix the contents of 1 Capsule with water to obtain a solution containing the equivalent of about 20 mg of paromomycin per mL. This test solution responds to the Identification test under Paromomycin Sulfate.

Disintegration 701: 15 minutes, the use of disks being omitted.

Uniformity of dosage units 905: meet the requirements.

Loss on drying 731— Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 7.0% of its weight.

Residual solvents 467: meet the requirements.

Assay— Proceed with Capsules as directed under Antibiotics—Microbial Assays 81, blending not less than 5 Capsules for 5 minutes in a high-speed blender with sufficient Buffer No. 3 to obtain a stock solution of convenient concentration. Dilute this stock solution quantitatively with the same buffer to obtain 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 1643

Phone Number : 1-301-816-8223