Iron Sodium Feredetate B.p.

Features of Iron Sodium Feredetate B.P. :-
Synonyms : Iron EDTA Complex
CAS No. : 15708-41-5
Description : A yellow or yellowish brown, spray dried powder hygroscopic.
Solubility : 10% w/v Easily soluble in water
Clarity : 1% solution in water clear without any sedimentation.
Identification : Passes as per B.P. (Test B & C)
Loss On Drying 4.0% to 13.5% at 120C
pH of 1% solution : 4.0-6.5
Bulk Density : 0.4 to 0.55
Free Iron : NMT 500ppm
Free Sodium Edetate : NMT 1%
Sulphates : NMT 600pppm
Total Microbial Count : Not Exceeding 1000 CFU per gm.by employing plate method of IP.
Pathogens:
Absent, as per method in I.P.
E. Coli : Absent
Salmonella : Absent
Shigella : Absent
Other Pathogens : Absent
Heavy Metals : NMT 20ppm Pb
Yeast and Mould : Absent
Assay : 98% to 102% (On dried bases)
Usage : As source of Iron in pharmaceutical preparations for making syrups, drops, tablets and capsules.
Can also be used in food products and veterinary preparations as source of Iron.
Statutory Details : FDA Approved Product.