Deferoxamine Mesylate for Injection
» Deferoxamine Mesylate for Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C25H48N6O8·CH4O3S.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 0.33 USP Endotoxin Unit per mg of deferoxamine mesylate.
pH 791: between 4.0 and 6.0, in a solution (1 in 100).
Water, Method I 921: not more than 1.5%.
Other requirements It meets the requirements under Injections 1 and Uniformity of Dosage Units 905.
Ferric chloride solution and Standard preparationPrepare as directed in the Assay under Deferoxamine Mesylate.
Assay preparation Constitute the contents of 1 vial in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a concentration of about 1 mg per mL.
Procedure Proceed as directed in the Assay under 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 C is the concentration, in mg per mL, of USP Deferoxamine Mesylate RS in the Standard preparation; V is the volume, in mL, of water used to prepare the Assay preparation; and AU and AS are the absorbances of the solutions obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 2063