Ferric carboxymaltose

Product name

Ferric Carboxymaltose

CAS No.

9007-72-1

Molecular Formula

C39H63FeO39

Molecular Weight

1211.74

Quality Standard

Assay of Iron ≥ 31%

Appearance

Yellow brown to brown powder

Test Items

Specifications

Results

Appearance

Yellow brown to brown powder

Brown powder

Identification for Iron

It responds to the test for iron

Positive reaction

Identification by TLC

The position and color of the spots shown by the sample solution are the same as the spot of standard solution (a)

The position and color of the spots shown by the sample solution should be the same as the spot of standard solution (a).

pH

5.0 - 7.0

5.6

Molecular weight determination (Da, by gel permeation chromatography (GPC))

Weight-average molecular weight (Mw) between 130,000 to 200,000

180,896

Number-average molecular weight (Mn) not less than 70,000

109,035

Polydispersity (Mw/Mn) not more than 1.9

1.66

Sodium Chloride content (w/w, on as is basis by Potentiometry)

≤ 6.0%

4.1

Limit of Fe(Ⅱ) (w/w, on as-is basis by potentiometry titration)

≤1.2%

0.07%

Residual solvents (by GC-HS)

Ethanol ≤ 0.5%

0.40%

Elemental impurities

(μg/g by ICP-MS)

Cd ≤ 0.2 μg/g

0.004 μg/g

As ≤ 0.2 μg/g

0.016 μg/g

Co ≤ 0.5 μg/g

0.343 μg/g

V ≤ 1.0 μg/g

0.028 μg/g

Ni ≤ 2.0 μg/g

0.127 μg/g

Cr ≤ 50 μg/g

0.219 μg/g

Mo ≤ 50 μg/g

0.050 μg/g

Cu ≤ 30 μg/g

0.040 μg/g

Li ≤ 25 μg/g

Not detected

Kb ≤ 0.5 μg/g

0.007 μg/g

Hg ≤ 0.3 μg/g

Not detected

Sb ≤ 9.0 μg/g

0.005 μg/g

Loss on drying (w/w)

<8.5%

6.8%

Bacterial endotoxin

< 0.1 EU/mg Fe

Conforms

Microbial limit

Total Aerobic Microbial count ≤ 100 cfu/g 

Conforms

Total Yeasts and Molds count ≤ 100 cfu/g 

Conforms

Escherichia coli: absent/g

Absent

Staphylococcus aureus: absent/g

Absent

Pseudomonas aeruginosa: absent/g

Absent

Salmonella: absent/10g

Absent

Assay of Iron

24.0% ~ 32.0%

31.1%

Assay of Dextrin

30.0% ~ 45.0%

37.0%