Iron (III) hydroxide Polymaltose complex (IPC -50 KD).

Name of Product

:

IRON (III) HYDROXIDE POLYMALTOSE COMPLEX 50 KD

Product Code

:

IPK

Sr. No.

Test

Specification

1.0

Description

Brown colored, amorphous powder.

2.0

Solubility

Soluble in 0.1M Hydrochloric acid

3.0

Identification

A) Iron (ferric iron)

To comply with the identification test.

B) Polymaltose

A reddish precipitate is produced & comply with the test.

4.0

pH (5.0 % Solution)

Between 5.0 and 7.0

5.0

Loss on Drying (105 C for 3 hours)

Not more than 10.0% w/w

6.0

Sodium Chloride Content

(On anhydrous basis)

Not more than 6.4 % w/w

7.0

Assay

A) Polymaltose content (On Anhydrous basis)

Between 25.0 and 50.0 % w/w

B) Iron content (On as is basis)

Between 25.0 and 35.0 % w/w

8.0

Molecular Weight Determination

A) Weight Average Molecular Weight (Mw)

Between 37000 and 73000 Da

B) Number Average Molecular Weight (Mn)

Between 29000 and 51000 Da

C) Polydispersity Index (Mw/Mn)

Not more than 1.7

9.0

Arsenic

Not more than 20 ppm

10.0

Copper

Not more than 60 ppm

11.0

Lead

Not more than 7 ppm 

12.0

Zinc

Not more than 150 ppm

13.0

Microbiological Limit Test

A) Total aerobic microbial count

Not more than 1000 cfu/gm

B) Total combined yeasts and molds count

Not more than 100 cfu/gm

C) Staphylococcus aureus

Should be absent

D) Salmonellae

Should be absent

E) E. coli

Should be absent

F) Pseudomonas aeruginosa

Should be absent