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  >> Gemfibrozil
CERTIFICATE OF ANALYSIS
Product: Gemfibrozil
Report Date: 2004-10-19
Batch No.: 041008
Manufacture Date: 2004-10-17
Batch Size: 1000Kg
Package: 25 Kg/Drum

Subject

USP26 Standard

Result

Description

White Crystalline powder

White Crystalline powder

Identification

Qualified

Qualified

Water

≤ 0.25 %

0.05%

Heavy Metals ( Pb )

≤ 0.002 %

< 0.002%

Related substances Chromatographic purity Gemfibrozil impurity A ≤0.1%

No trace

Secondary impurity ≤ 0.1%

0.025%

Total impurity ≤0.5%

0.087%

Organic volatile impurities

Qualified

Qualified

Relict Scorch

≤ 0.1%

0.02%

Melting Point

58 - 61 ℃

58.5 - 60.0 ℃

Content

98% ~ 102%

99.93%

Conclusion: Up To USP26 Standard.
Director: Wenmin Pan Inspector: Yan Fang Reviewer: Wenmin Pan
 
 
 
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