Paromomycin Sulfate Capsules
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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.
USP Reference standards 〈11〉—
USP Paromomycin Sulfate RS
Identication—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 Antibiotics—Microbial Assays 〈81〉, blending not less than 5 Capsules for 5 minutes in a high speed blender with sufficient Buffer B.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.
