U.S. PHARMACOPEIA

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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.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 590
Phone Number : 1-301-816-8223