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  >> Nefazodone Hydrochloride
CERTIFICATE OF ANALYSIS

Product: Nefazodone Hydrochloride

Report Date: 2004-02-05

Batch No: 040201

Manufacture Date: 2004-02-02

Batch Size: 50kg

Expiry Date: 2006-02-02

Package: 25 Kg/Drum

 

Subject

Enterprise Standard

Result

Appearance

White or Off-white crystalline powder

White crystalline Powder

Solubility

Ethanol-slightly soluble

Pass

Dichloromethane-slight solube

Pass

Water-very slightly solube

Pass

Identification

IR spectrum is concordant with the spectrum of RS

Pass

Melting point

186.0 ℃-188.0 ℃

186.0 ℃-187.0 ℃

Loss On Drying

≤ 0.5%

0.20%

Heavy Metals

≤ 10PPM

Pass

Assay

≥ 99.0% ( HPLC )

99.6%

Chromatographic purity triazolone total

≤ 0.1%

≤ 0.5%

Pass

Pass

Conclusion: Comply with the required enterprise standards

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