SPL Set ID: 3f109bdb-a412-43b2-84c7-9dad05e85a71

Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous solution, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection, USP is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L. Structural Formula