Product Name: Ferric Carboxymaltose

Alias: Ferinject; Injectafer; Iron Dextri-Maltose; Ferric Carboxymaltos; Ferric carboxymahose

CAS No.: 9007-72-1

EINECS No.: 813-933-0

Molecular Formula: C39H63FeO39

Molecular Weight: 1211.73912

Introduction:
Ferric carboxymaltose is a new type of intravenous iron preparation, which is a complex formed by a trivalent polynuclear iron core (β-FeOOH) surrounded by carboxymaltodextrin (the oxidation product of maltodextrin) (codenamed "VIT- 45"), this core-shell structure can stably complex iron and control the release of iron, thus preventing toxic oxides produced by saturation of ferroportin and ferritin due to excessive blood iron concentration. Iron carboxymaltose contains high iron content (24-32%, the iron content in its injection is 47.5-52.5mg/mL, and 500-1500mg of iron can be quickly injected within 15 minutes), the frequency of administration is small, and the iron supplement effect is good and large. It improves patient compliance to a certain extent and is a good intravenous iron supplement.

Specifications of our Ferric Carboxymaltose:

Test Items		Specifications
Description		Red-brown powder
Identification	A: Iron (Ferric)	Positive
	B: Dextrin	Meets the requirements
	C: Molecular Weight determination	Mw=110,000~230,000 Da  Mn≥60,000 Da Mw/Mn≤1.9
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 (Ⅱ)		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
Microbial Limits	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)

Packaging:
1kg/Aluminum Foil Bag or 10kg/Carton.

Storage Conditions:
Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.

Shelf Life:
36 months if stored under above mentioned conditions.