NIZATIDINE
Item
Standard
Resulte
Description
White or analogous white crystailine powder
Conforms
Related substance
≤1.0%
<1.0%
Heary metals
≤10ppm
<10ppm
Arsenci
≤1ppm
<1ppm
Residue on lgnition
≤0.1%
0.06%
Loss on drying
≤0.5%
0.15%
Tretinoin
≤5.0%
Assay
≥98.0%
99.1%
Total plate counmt
≤1000CFU/g
<100CFU/g
Moulds+yeasts
≤100CFU/g
<10CFU/g
Escherichia Coli
Negative in 10g
conformed
Salmonella spp.
Negative in 25g
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