This is once again a strong member of our haematinic product range. The iron exists in ferric form, complexed with polymaltose. This is a non-ionic complex and charge of iron is completely shielded. This ensures maximum absorption in the body. The speciality of this product is iron is completely hydrolysed, and it remains completely soluble in very wide range of pH or one can state that the product remains soluble without giving turbidity in 0.1 N HCl solution also. The complex is stabilized in such a way that the polymaltose content remains at its highest level. This ensures excellent stability and high absorption of iron from the formulation our API can be comfortably used for liquid, tablets, capsules & drops formulations.
Specifications:
Tests | Specifications |
---|---|
Description | Reddish deep brown coloured amorphous powder |
Solubility | Soluble in 0.1M Hydrochloric acid and easily soluble in hot water |
Identification: For Iron For Polymaltose | To comply the identification test |
pH 5.0 % solution | Between 5.0 and 6.5 |
Absence of Oligomaltose & ligoisomaltose | To be absent |
Ionic Iron | To be absent |
Water Content (By KF) | Not more than 7.0 % w/w |
Sodium Chloride (on anhydrous basis) | Not more than 6.4 % w/w |
Limit test | - |
Arsenic | Not more than 2 ppm |
Copper | Not more than 60 ppm |
Lead | Not more than 25 ppm |
Zinc | Not more than 150 ppm |
Assay: Elemental Iron (On as is basis) Polymaltose (On Anhydrous basis) | Between 28.0 % to 40.0 % |
Microbial Limit Test | - |
Microbial Count | NMT 1000 cfu/gm |
Yeast & Moulds | NMT 100 cfu/gm |
Staphylococcus aureus | To be absent |
Salmonellae | To be absent |
E. Coli | To be absent |
Pseudomonas aeruginosa | To be absent |
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