Colistimethate for Injection
»Colistimethate for Injection contains an amount of Colistimethate Sodium equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of colistin.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ It contains not more than 2.0USP Endotoxin Units per mg of colistin.
Sterility á71ñ It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Other requirements— It responds to the Identificationtest and meets the requirements for pH,Loss on drying,Heavy metals,and Free colistinunder Colistimethate Sodium.It meets also the requirements for Uniformity of Dosage Units á905ñand for Constituted Solutionsand Labelingunder Injections á1ñ.
Assay—
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Colistimethate for Injection in a volume of water,accurately measured,corresponding to the volume of diluent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and quantitatively dilute with Buffer No.6to obtain a solution having a convenient concentration.
Assay preparation 2 (where the label states the quantity of colistin equivalent in a given volume of constituted solution)—Constitute Colistimethate for Injection in a volume of water,accurately measured,corresponding to the volume of diluent specified in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with Buffer No.6to obtain a solution having a convenient concentration.
Procedure— Proceed as directed for Colistimethate Sodium under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted 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 541
Phone Number:1-301-816-8335