Deferoxamine Mesylate
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C25H48N6O8·CH4O3S 656.79

Butanediamide,N¢-[5-[[4-[[5-(acetylhydroxyamino)pentyl]amino]-1,4-dioxobutyl]hydroxyamino]pentyl]-N-(5-aminopentyl)-N-hydroxy-,monomethanesulfonate.
N-[5-[3-[(5-Aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N-hydroxyacetamido)pentyl]carbamoyl]propionohydroxamic acid monomethanesulfonate (salt) [138-14-7].
»Deferoxamine Mesylate contains not less than 98.0percent and not more than 102.0percent of C25H48N6O8·CH4O3S,calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers.
Labeling— Where it is intended for use in preparing injectable dosage forms,the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification— Dissolve 5mg in 5mLof water,add 2mLof tribasic sodium phosphate solution (1in 200),mix,then add 10drops of b-naphthoquinone-4-sodium sulfonate solution (1in 40):a blackish brown color is produced.
pHá791ñ: between 4.0and 6.0,in a solution (1in 100).
Water,Method Iá921ñ: not more than 2.0%.
Residue on ignition á281ñ: not more than 0.1%,2.0g being used.
Chloride á221ñ— A1.2-g portion shows no more chloride than corresponds to 0.20mLof 0.020Nhydrochloric acid (0.012%).
Sulfate á221ñ— A0.5-g portion shows no more sulfate than corresponds to 0.20mLof 0.020Nsulfuric acid (0.04%).
Other requirements— Where the label states that Deferoxamine Mesylate is sterile,it meets the requirements for Sterility Tests á71ñand Labelingunder Injections á1ñ,and Bacterial endotoxinsunder Deferoxamine Mesylate for Injection.Where the label states that Deferoxamine Mesylate must be subjected to further processing during the preparation of injectable dosage forms,it meets the requirements for Bacterial endotoxinsunder Deferoxamine Mesylate for Injection.
Assay—
Ferric chloride solution— Dissolve 6.7g of ferric chloride in dilute hydrochloric acid (1in 100)in a 100-mLvolumetric flask.Add dilute hydrochloric acid (1in 100)to volume,mix,and filter.
Standard preparation— Dissolve a suitable quantity of USP Deferoxamine Mesylate RS,accurately weighed,in water to obtain a solution having a known concentration of about 1000µg per mL.
Assay preparation— Dissolve about 50mg of Deferoxamine Mesylate,accurately weighed,in water to make 50.0mL,and mix.
Procedure— Pipet 2mLeach of the Standard preparation,the Assay preparation,and water to provide a blank,into separate 25-mLvolumetric flasks.To each flask add 3mLof Ferric chloride solution,dilute with water to volume,and mix.Concomitantly determine the absorbances of the solutions from the Standard preparationand the Assay preparationagainst the blank,in 1-cm cells,at the wavelength of maximum absorbance at about 485nm,with a suitable spectrophotometer.Calculate the quantity,in mg,of C25H48N6O8·CH4O3Sin the portion of Deferoxamine Mesylate taken by the formula:
0.05C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Deferoxamine Mesylate RSin the Standard preparation,and AUand ASare the absorbances of the solutions from the Assay preparationand Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 575
Pharmacopeial Forum:Volume No.29(5)Page 1448
Phone Number:1-301-816-8251