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Iron (III) Hydroxide Polymaltose Complex

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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:

TestsSpecifications
DescriptionReddish deep brown coloured amorphous powder
SolubilitySoluble in 0.1M Hydrochloric acid and easily soluble in hot water
Identification:
For Iron
For Polymaltose

To comply the identification test
To comply the identification test

pH 5.0 % solutionBetween 5.0 and 6.5
Absence of Oligomaltose & ligoisomaltoseTo be absent
Ionic IronTo 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-
ArsenicNot more than 2 ppm
CopperNot more than 60 ppm
LeadNot more than 25 ppm
ZincNot more than 150 ppm
Assay:
Elemental Iron (On as is basis)
Polymaltose (On Anhydrous basis)

Between 28.0 % to 40.0 %
Between 32.0 % to 50.0 %

Microbial Limit Test-
Microbial CountNMT 1000 cfu/gm
Yeast & MouldsNMT 100 cfu/gm
Staphylococcus aureusTo be absent
SalmonellaeTo be absent
E. ColiTo be absent
Pseudomonas aeruginosaTo be absent