NIZATIDINE

Characteristics: The Sample is white or analogous white crystalline powder.

Test:

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%

<1.0%

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

conformed

Conclusion: The sample meets the specifications.

 

 
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