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  >> Fexofenadine Hydrochloride
CERTIFICATE OF ANALYSIS

Product: Fexofenadine Hydrochloride

Report Date: 2004-07-08

Batch No.: 040525

Manufacture Date: 2004-05-25

Batch Size: 100Kg

Package: 25Kg/drum

Subject

Enterprise Standard

Result

Description

White Crystalline powder

White Crystalline Powder

Melting Point

195.0 - 199.0 ℃

195.3 - 198.9 ℃

IR-Spectrum

Qualified

Qualified

Heavy Metals ( Pb )

< 20ppm

< 20ppm

Chromatographic purity

Qualified

Qualified

Relict Scorch

≤ 0.1%

0.03%

Loss On Drying

≤ 0.1%

0.05%

Assay

≥ 98%

99.18%

Conclusion : Up To Enterprise Standard.

Director: Wenmin Pan Inspector: Yan Fang Reviewer: Wenmin Pan

 
 
 
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