Deferoxamine Mesylate for Injection
»Deferoxamine Mesylate for Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C25H48N6O8·CH4O3S.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— It responds to the Identificationtest under Deferoxamine Mesylate.
Bacterial endotoxins á85ñ— It contains not more than 0.33USP Endotoxin Unit per mg of deferoxamine mesylate.
pHá791ñ: between 4.0and 6.0,in a solution (1in 100).
Water,Method Iá921ñ: not more than 1.5%.
Other requirements— It meets the requirements under Injections á1ñand Uniformity of Dosage Units á905ñ.
Assay—
Ferric chloride solution and Standard preparation—Prepare as directed in the Assayunder Deferoxamine Mesylate.
Assay preparation— Constitute the contents of 1vial in water,and dilute quantitatively,and stepwise if necessary,with water to obtain a solution having a concentration of about 1mg per mL.
Procedure— Proceed as directed in the Assayunder Deferoxamine Mesylate.Calculate the quantity,in mg,of deferoxamine mesylate (C25H48N6O8·CH4O3S)in the vial of Deferoxamine Mesylate for Injection taken by the formula:
CV(AU/AS),
in which Cis the concentration,in mg per mL,of USP Deferoxamine Mesylate RSin the Standard preparation;Vis the volume,in mL,of water used to prepare the Assay preparation;and AUand ASare the absorbances of the solutions obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 575
Phone Number:1-301-816-8251