Libraw Pharma
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Libraw Pharma
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Libraw Pharma
Sodium Starch Glycollate I.P.
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Parameters Specification Result
Description Very Fine, White or off White, Free flowing Powder, Odourless or almost odourless. Fine, White, Odourless powder
Solubility Practically Insoluble in water Insoluble in most organic solvents. Complies
Identification
A Infra-red absorption spectrum should concordant with IP reference standards Concord with IP reference (IR spectrum is enclosed)
B Should comply Complies
C Should comply Complies
pH 5.5 to 7.5 6.4
Loss on Drying% NMT 10 6.6
Iron% NMT 0.002 Passes
Heavy Metal NMT 0.002 Passes
Sodium Chloride% NMT 10 6.7
Assay, as Sodium% 2.8 to 4.5 3.1
Sodium Glycollate% NMT 2 Passes
Swelling volume ml* NLT 40 50
Note : *Also conforms to In-house Specifications.

Microbiological Analysis
Parameters Specifications Result
*Total Aerobic Microbial Count, CFU/g NMT 1000 200
*Total Yeast and Mould Count, CFU/g NMT 100 <10
Escherichia coli, per 1 g Absent Absent
Salmonella sp. per 1 g Absent Absent
Note : *Also conforms to In-house Specifications.

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