Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Trading Company
Tel: 86-571-87072300
Mobile: 86-18268089214
Tel: 86-571-87072300
Fax:
URL: http://www.clakebiotech.com
Province/state: zhejiang
City: hangzhou
Street: RM.305,BLOCK 7A,ECOLOGICAL CLUSTER,XIHU DISTRICT,HANGZHOU,CHINA
MaxCard:
USP26/USP31 ;
1. Pharm grade grade
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
ITEMS |
SPECIFICATION |
RESULTS |
Appearance |
White to yellowish hygroscopic powder or flakes with slight characteristic odor |
Conforms |
Identification |
Positive |
Conforms |
Solubility |
Freely soluble in water ,in chloroform and in ethanol (95%),practically in soluble in ether |
Conforms |
Appearence of solution |
Solution A is clear and not more intensely coloured than reference solution BS6 or BYS6 |
Conforms |
Water % |
≤5.0 |
1.0 |
pH |
3.0~5.0 |
4.0 |
Sulphated ash % |
≤0.1 |
0.06 |
Impurity A |
≤10 |
0.26 |
Impurity B (2-pyrrolldone)ppm |
≤3.0 |
1.0 |
Heavy metals (Expressed as Lead)ppm |
≤10 |
<10 |
Aldehydes % |
≤0.05 |
0.003 |
Nitrogen content % |
11.5~12.8 |
12.1 |
K-Value |
23.0~32.0 |
30 |
Hydrazine,ppm |
≤1.0 |
Conforms |
Hydrogen peroxide,ppm |
≤400 |
Conforms |
Formic acid,% |
≤0.5 |
0.01 |
Total aerobic plate count,CFY/g |
≤100 |
<10 |
Total mold/yeast,cfu/g |
≤100 |
<10 |
E.coli cfu/g |
Negative |
Conforms |
Staphylococcus aureus CFU/g |
Negative |
Conforms |
Pseudomonas aeruginosa CFU/g |
Negative |
Conforms |
Salmonella CFU/g |
Negative |
Conforms |
Conclusion: The product complies with USP/BP standard |