HANGZHOU CLAKE BIOTECH CO.,LTD
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Business Type:Trading Company
Tel: 86-571-87750367
Mobile: 86-18268089214
Tel: 86-571-87750367
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URL: http://www.clakebiotech.com
Province/state: zhejiang
City: hangzhou
Street: RUIBO INTERNATIONAL ,HANGZHOU ,CHINA
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CAS NO.128-13-2
1. GMP AVALIABLE ;
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
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NATURE OF TEST |
QUALITY STANDARD |
TEST RESULTS |
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CHARACTERS: |
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-Appearance |
White or almost white powder |
Conforms |
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-Solubility |
Practically insoluble in water, freely |
Conforms |
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soluble in ethanol (96 per cent), slightly |
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soluble in acetone, practically insoluble in |
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methylene chloride. |
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TESTS: |
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-Melting point |
About 202 ℃ |
202℃ |
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-Identification |
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- IR |
The spectrum obtained is similar to |
Conforms |
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that of CRS |
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-Sepcific optical rotation |
+ 58.0~+62.0 |
+61.3° |
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-Sulphate Ash |
≤ 0.1 % |
0.04% |
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-Related substances(TLC) |
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|
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- Chenodeoxycholic Acid |
≤ 1 % |
< 1 % |
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- Lithocholic Acid |
≤ 0.1 % |
not detected |
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- Cholic Acid |
≤ 0.5 % |
not detected |
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- any other impurity |
≤ 0.25 % |
not detected |
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-Loss on Drying |
≤ 1.0 % |
0.04% |
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-Heavy metal |
≤ 20 ppm |
< 20 ppm |
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ASSAY : |
99.0 %~101.0 % |
100.7% |
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-On dry substance |
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CONCLUSION: THE TEST RESULTS CONFORM TO EP |
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RESIDUAL SOLVENTS: |
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- Methanol |
≤3000 ppm |
not detected |
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- Isopropanol |
≤5000 ppm |
not detected |
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- Ethylacetate |
≤5000 ppm |
not detected |
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MICROBIOLOGICAL TESTS: |
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-Total Plate Count /1 g |
＜ 1000 |
＜ 10 |
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-Yeast & Mould /1 g |
＜ 100 |
＜ 10 |
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-E. coli /1 g |
Absent |
Absent |
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CONCLUSION: THE TEST RESULTS CONFORM TO MICROBIOLOGICAL TESTS. |
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