Deferoxamine Mesylate for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Deferoxamine Mesylate for Injection contains NLT 90.0% and NMT 110.0% of the labeled amount of deferoxamine mesylate (C₂₅H₄₈N₆O₈ · CH₄O₃S).

2 IDENTIFICATION

A.

Sample: 5 mg of Deferoxamine Mesylate for Injection

Analysis: Dissolve the Sample in 5 mL of water, add 2 mL of tribasic sodium phosphate solution (1 in 200), mix, then add 10 drops of β-naphthoquinone-4-sodium sulfonate solution (1 in 40).

Acceptance criteria: A blackish brown color is produced.

3 ASSAY

3.1 Procedure

Solution A: Dissolve 6.7 g of ferric chloride in dilute hydrochloric acid (1 in 100) in a 100-mL volumetric flask. Add dilute hydrochloric acid (1 in 100) to volume.

Standard solution: 1 mg/mL of USP Deferoxamine Mesylate RS

Sample solution: Nominally 1 mg/mL, prepared as follows. Constitute the contents of 1 vial in water, and dilute with water to volume.

Instrumental conditions

• (See Ultraviolet-Visible Spectroscopy 〈857〉.)
• Mode: Vis
• Analytical wavelength: 485 nm
• Cell: 1 cm
• Blank: Water

Analysis

Samples: Standard solution, Sample solution, and Blank

Pipet 2 mL each of the Standard solution, Sample solution, and Blank into separate 25-mL volumetric flasks. To each flask add 3 mL of Solution A, and dilute with water to volume. Concomitantly determine the absorbances.

Calculate the percentage of the labeled amount of deferoxamine mesylate (C₂₅H₄₈N₆O₈ · CH₄O₃S) in the portion of Deferoxamine Mesylate for Injection taken:

Result = (A_U/A_S) × (C_S/C_U) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Deferoxamine Mesylate RS in the Standard solution (mg/mL)

C_U = nominal concentration of deferoxamine mesylate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Uniformity of Dosage Units 〈905〉: Meets the requirements

5 SPECIFIC TESTS

pH 〈791〉: 4.0–6.0, in a solution (1 in 100)

Water Determination, Method I〈921〉: NMT 1.5%

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

Bacterial Endotoxins Test 〈85〉: NMT 0.33 USP Endotoxin Unit/mg of deferoxamine mesylate

Constituted Solution: At the time of use, it meets the requirements in Injections and Implanted Drug Products 〈1〉, Specific Tests, Completeness and clarity of solutions.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

USP Reference Standards 〈11〉

USP Deferoxamine Mesylate RS