Paromomycin Sulfate Capsules
» Paromomycin Sulfate Capsules contain the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of paromomycin (C23H45N5O14).
Packaging and storage Preserve in tight containers.
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.
Assay Proceed with Capsules as directed under AntibioticsMicrobial 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.
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USP32NF27 Page 3213