HANGZHOU CLAKE BIOTECH CO.,LTD
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Country: 
China (Mainland)
Business Type:Trading Company
Tel: 86-571-87072300
Mobile: 86-18268089214
Tel: 86-571-87072300
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URL: http://www.clakebiotech.com
Province/state: zhejiang
City: hangzhou
Street: RM.305,BLOCK 7A,ECOLOGICAL CLUSTER,XIHU DISTRICT,HANGZHOU,CHINA
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|
ITEM |
SPECIFICATIONS |
RESULTS |
|
Characteristics |
White or almost white crystalline powder or colourless crystals |
white crystalline powder |
|
Identification |
Corresponds |
Corresponds |
|
Melting point |
189℃~193℃ |
191℃ |
|
pH （5%，W/V） |
2.1-2.6 |
2.28 |
|
pH （2%，W/V） |
2.4-2.8 |
2.48 |
|
Specific optical rotation |
+20.5°－+21. 5° |
+20.9° |
|
Apperance of solution |
Solution S is clear and not more intensely cloured than reference solution BY7 |
Up to standard |
|
Heavy metals |
≤10ppm |
＜10ppm |
|
Assay |
99.0%-100.5% |
99.2% |
|
Copper |
≤5ppm |
0.21ppm |
|
Iron |
≤2ppm |
0.12ppm |
|
Mercury |
≤1ppm |
0.05ppm |
|
Arsenic |
≤3ppm |
＜3ppm |
|
Lead |
≤2ppm |
0.07ppm |
|
Oxalic acid (impurity E:) |
≤0.2% |
＜0.2% |
|
Loss on drying |
≤0.4% |
0.02% |
|
Sulphated ash |
≤0.1% |
0.02% |
|
Related substances: |
||
|
Impurity C |
≤0.15% |
＜0.01% |
|
Impurity D |
≤0.15% |
＜0.01% |
|
Unspecified impurities |
≤0.10% |
ND |
|
Total |
≤0.20% |
ND |
|
Residual solvents: |
||
|
Methanol |
≤3000 ppm |
100ppm |
|
Microbiological examination |
||
|
TAMC |
103 cfu/g |
Corresponds |
|
TYMC |
102 cfu/g |
Corresponds |
|
E.coli |
Absence |
Corresponds |
|
Conclusion: Conforms to the standard of BP2014/USP38/E300/FCC7 |
||