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 90.0percent and not more than 120.0percent of the labeled amount of colistin.
Packaging and storage— Preserve in tight containers,protected from light.
Uniformity of dosage units á905ñ—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 5.0and 6.0,in the suspension constituted as directed in the labeling.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours: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 á81ñusing an accurately measured volume of this suspension,freshly mixed and free from air bubbles,diluted quantitatively with Buffer No.6to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 542
Phone Number:1-301-816-8335