Iron Sorbitol Citric Acid Complex 17%(pyrogen Free)

Parameters of Iron Sorbitol Citric Acid Complex 17%(Pyrogen Free) :-
Synonyms :
I : Ferric Sorbitol Citric Acid Complex (Pyrogen Free)
II : Iron Sorbitol Complex (Pyrogen Free)
Description : Dark brown coloured amorphous powder, without any odour, and, only a feeble astringent taste.
Solubility : Easily soluble in hot water (1 gm in 10ml). Insoluble in organic solvents, and precipitates on mixing aqueous solution with water miscible organics solvents like alcohol and acetone.
Identification :
Ferric Iron : It gives blue colour with Ferrocyanide.
Carbohydrates :It gives green colour with Anthrone Reagent.
Loss On Drying : N.M.T 7% as loss on drying at 1050C
pH : pH of a 30% solution in water is between 7.5 to 8.5
Bulk Density : 0.9 to 1.01 (On Tapped Density Apparatus)
Chlorides As NaCl : Less than 3%
Total Microbial Count : Not Exceeding 100 CFU per gm. (By employing plate method)
Pathogens : Absent
Endotoxin : Less than 0.5 EU/ mg
Heavy Metals : Not more than 70 ppm
Arsenic : NMT 2 ppm
Copper : NMT 60 ppm
Lead : NMT 25 ppm
Zinc : NMT 150 ppm
Assay of Iron : 15% to 19% w/w
Assay of Dextrin : 44% to 54% w/w
Assay Of Sorbitol : 11.8% to 15.4%
Usage :As source of Iron, in Pharmaceutical preparations for Specialty purpose were pyrogen free product is required.
Commercial Information :
Packing : In 5kgs and 25kgs HDPE Drums.
Delivery : Within 15 days, Ex- Navi Mumbai.
Rates : On request, subject to change without notice.
Statutory Details : FDA Appr