Product: Nefazodone Hydrochloride
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Report Date: 2004-02-05
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Batch No: 040201
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Manufacture Date: 2004-02-02
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Batch Size: 50kg
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Expiry Date: 2006-02-02
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Package: 25 Kg/Drum
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Subject
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Enterprise Standard
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Result
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Appearance
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White or Off-white crystalline powder
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White crystalline Powder
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Solubility
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Ethanol-slightly soluble
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Pass
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Dichloromethane-slight solube
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Pass
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Water-very slightly solube
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Pass
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| Identification |
IR spectrum is concordant with the spectrum of RS
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Pass
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Melting point
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186.0 ℃-188.0 ℃
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186.0 ℃-187.0 ℃
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Loss On Drying
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≤ 0.5%
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0.20%
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Heavy Metals
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≤ 10PPM
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Pass
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Assay
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≥ 99.0% ( HPLC )
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99.6%
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Chromatographic purity triazolone total
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≤ 0.1% ≤ 0.5%
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Pass Pass
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Conclusion: Comply with the required enterprise standards
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