 |
|
Fexofenadine Hydrochloride
|
|
Rofecoxib
|
Cafferic acid phenethyl ester (CAPE)
|
|
Donepezil
|
1-Benzyl-4-formylpiperidine
|
5,6-Dimethoxy-1-indanone
|
3,4-Dihydroxybenzaldehyde
|
2-Aminopyrimidine
|
2-Chloro( or Bromo) pyrimidine
|
2-Hydroxypyrimidine Hydrochloride
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CERTIFICATE OF ANALYSIS
Product: Gemfibrozil
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Report Date: 2004-10-19 |
Batch No.: 041008
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Manufacture Date: 2004-10-17 |
Batch Size: 1000Kg
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Package: 25 Kg/Drum |
Subject
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USP26 Standard
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Result
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Description
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White Crystalline powder
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White Crystalline powder
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Identification
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Qualified
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Qualified
|
Water
|
≤ 0.25 %
|
0.05%
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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
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≤ 0.1%
|
0.02%
|
Melting Point
|
58 - 61 ℃
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58.5 - 60.0 ℃
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Content
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98% ~ 102%
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99.93%
|
| Conclusion: Up To USP26 Standard. |
Director: Wenmin Pan Inspector: Yan Fang Reviewer: Wenmin Pan
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Copyright(C)2005,Zhejiang Excel Pharmaceutical Co., Ltd. .
Supported by ChemNet ChinaChemNet GoldTrust |
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