IRON (III) HYDROXIDE POLYMALTOSE COMPLEX 34%

Description

Sr. No.	Test Parameter	Specification	Reference
1.0	Description	Reddish brown to brown coloured spray dried powder.	In-house
2.0	Identification:		In-house
2.1	Test for Iron / Iron (III) Bound	To be positive.	In-house
2.2	Test for Polymaltose	To be positive.	In-house
2.3	Test for Oligomaltose	To be negative.	In-house
2.4	Ionized/free iron (III)	To be negative.	In-house
3.0	Solubility (5 % w/v.)	Soluble in water. Insoluble in organic solvent	In-house
4.0	pH ( 5 % w/v. solution)	5.50 – 7.50 at 27 ⁰C	In-house
5.0	Loss on drying	Not more than 8.00 % w/w.	In-house
6.0	Total elemental iron	26.00 – 36.00 % w/w. (On dri ed basis)	In-house
7.0	Polymaltose content	25.00 – 50.00 % w/w.	In-house
8.0	Sodium chloride content	Not more than 3.00 % w/w.	In-house
9.0	Arsenic	Not more than 3 ppm.	In-house
	Mercury	Not more than 3 ppm.	In-house
	Lead	Not more than 25 ppm.	In-house
	Cadmium	Not more than 25 ppm.	In-house
	Copper	Not more than 60 ppm.	In-house
	Zinc	Not more than 150 ppm.	In-house
10.0	Total aerobic microbial count	Not more than 1000 CFU /gm.	In-house
11.0	Total combined yeast and mould count	Not more than 100 CFU /gm.	In-house
12.0	Enterobacteriaceae count	Not more than 10 CFU /gm.	In-house
13.0	Pathogen
13.1	E. coli.	To be absent.	In-house
13.2	S. typhi	To be absent.	In-house
13.3	S. aureus	To be absent.	In-house
13.4	P. aeruginosa	To be absent.	In-house

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