IRON (III) HYDROXIDE POLYSACCHARIDE COMPLEX

Description

SR. No.	Test	Specification	Reference
1.0	Description	Brown to black coloured fine free flowing spray dried powder.	In-house
2.0	Identification		In-house
2.1	Iron (III) Bound	To be present.	In-house
2.2	Ferric ions	Not more than 0.5 %. w/w.	In-house
3.0	Solubility (5 % w/v.)	Soluble in water. Insoluble in organic solvent.	In-house
4.0	Free alkali	pH not more than 7.5 at 27°C	In-house
5.0	pH (5 % w/v. solution)	9.00 – 11.00 at 27 °C	In-house
6.0	Loss on drying	Not more than 8.00 % w/w.	In-house
7.0	Assay (as Total elemental iron)	42.00 – 48.00 % w/w.	In-house
8.0	Sodium chloride	Not more than 3.50 % w/w.	In-house
9.0	Arsenic	NMT 3 ppm.	In-house
	Mercury	NMT 3 ppm.	In-house
	Lead	NMT 25 ppm.	In-house
	Cadmium	NMT 25 ppm.	In-house
	Copper	NMT 60 ppm.	In-house
	Zinc	NMT 150 ppm.	In-house
10.0	Particle Size
	Retained on 100 Sieve	NMT 1.00%w/w.	In-house
	Retained on 200 Sieve	NMT 10.00%w/w.	In-house
	Retained on 325 Sieve	NMT 30.00%w/w.	In-house
11.0	Total aerobic microbial count	NMT 1000 CFU /gm.	In-house
12.0	Total combined yeast and mould count	NMT 100 CFU /gm.	In-house
13.0	Enterobacteriaceae count	NMT 10 CFU /gm.	In-house
14.0	Pathogen
14.1	E. coli.	To be absent.	In-house
14.2	S. typhi	To be absent.	In-house
14.3	S. aureus	To be absent.	In-house
14.4	P. aeruginosa	To be absent.	In-house

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