Colistin Sulfate for Oral Suspension
» Colistin Sulfate for Oral Suspension is a dry mixture of Colistin Sulfate with or without one or more suitable buffers, colors, diluents, dispersants, and flavors. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of colistin.
Packaging and storage— Preserve in tight containers, protected from light.
USP Reference standards 11
USP Colistin Sulfate RS Click to View Structure
Uniformity of dosage units 905
for solid packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 6.0, in the suspension constituted as directed in the labeling.
Loss on drying 731 Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 3.0% of its weight.
Assay— Constitute Colistin Sulfate for Oral Suspension as directed in the labeling. Proceed as directed under Antibiotics—Microbial Assays 81 using an accurately measured volume of this suspension, freshly mixed and free from air bubbles, diluted quantitatively with Buffer No. 6 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 2768