Business Type:Trading Company
Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Trading Company
CAS NO.104376-79-6
ep7/usp 34
items |
standard |
result |
appearance |
almost white yellowish, crystalline powder,slight hygroscopic |
almost white powder slight hygroscopic |
identification |
conform |
conform |
specific optical rotation |
-155 -170 |
-159 |
crysttallinity |
conform |
conform |
clarity of solution |
should be clarified |
conform |
ph |
6.0-8.0 |
7.2 |
water |
8.0-11.0% |
9.1% |
sterility |
conform |
conform |
n,n-dimethylaniline |
0.0020% max |
not detected |
2-ethylhexyl acid |
0.8% max |
0.005% |
single impurity |
1.0% max |
0.2% |
total impurity |
4.0% max |
0.5% |
bacteral endotoxins |
0.08iu/mg max |
conform |
sub-visible particles |
2250 particles/g max(10um min) 225 particles/g max(25um min) |
706particles/g 72particles/g |
potency,dry base |
96.0-102.0% |
99.8% |
conclusion |
complies with standard ep7.0 |