Business Type:Trading Company
Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Trading Company
CAS NO.50-56-6
standards basis |
european pharmacopoeia 8.0 |
||
storage |
cool dry place, away from light |
||
test |
specifications |
results |
|
apperarance |
white or almost white, hygroscopic powder |
conforms |
|
identification |
hplc: rt same as reference standard |
conforms |
|
amino acid composition |
gly:0.90-1.10 leu: 0.90-1.10 pro: 0.90-1.10 cys:1.4-2.1 asp:0.90-1.10 glu:0.90-1.10 ile: 0.90-1.10 tyr: 0.7-1.05 |
1.00 1.00 1.00 1.80 1.00 1.00 1.00 0.90 |
test |
specifications |
results |
ph |
3.0~6.0 |
4.7 |
water content |
karl fischer:≤5.0% |
2.04% |
acetate content |
6.0%~ 10.0% |
6.38% |
related substance (hplc) |
total impurities(%) ≤ 5.0% |
1.21% |
single impurity(%) ≤ 1.5% |
0.61% |
|
acetonitrile |
≤0.041% |
conforms |
assay(by anhydrous, acetate -free ) |
93.0~102.0% |
100.2% |
bacterial endotoxins |
<300eu/mg |
conforms |
conclusion |
complies with ph eur 8.0 |