Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Paromomycin Sulfate RS.

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

Disintegration á701ñ: 15minutes,the use of disks being omitted.

Uniformity of dosage units á905ñ: meet the requirements.

Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at 60for 3hours:it loses not more than 7.0%of its weight.

Assay— Proceed with Capsules as directed under Antibiotics—Microbial Assays á81ñ,blending not less than 5Capsules for 5minutes in a high-speed blender with sufficient Buffer No.3to obtain a stock solution of convenient concentration.Dilute this stock solution quantitatively with the same buffer to obtain 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 1473

Phone Number:1-301-816-8335