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 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
701 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3213