Ferric Carboxymaltose

Description: Red-brown powder; Identification A (Iron): Positive; Identification B(Dextrin): Meets the requirements; pH Value: 5.0 7.0; Loss on Drying: Not more than 10.0%; Content of Chloride: Not more than 6.0%; Limit of Iron (2+): Not more than 1.2%; Arsenic (As): Not more than 11 ppm; Cuprum (Cu): Not more than 320 ppm; Lead (Pb): Not more than 135 ppm; Total aerobic microbial count: Not more than 100 CFU/g; Moulds & Yeasts: Not more than 10 CFU/g; Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa: Negative/g; Salmonella: Negative/10g; Bacterial endotoxins: Less than 0.1 EU/mg Iron; Assay for Iron: 24.0% 32.0% (on the anhydrous basis); Assay for dextrin (as glucose): 25.0% 50.0% (on the anhydrous basis)