oxytocin oxytocin raw material 50-56-6
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oxytocin pharmaceutical grade specification
Items |
Specifications |
Results |
Characters |
White or yellowish white powder |
Conforms |
Idenfication (HPLC)
Bioassay |
Retention time conforms to that of reference Should Conform to standard |
Conforms5.0% Conforms |
Examination |
||
Microbial Counts
|
3.0-6.0 |
5.2 |
|
≤5.0% |
4.0% |
|
Individual ≤ 1.5% Toegether ≤5.0% |
0.4% 1.5% |
|
Asp 0.90-1.10 Glu 0.90-1.10 Pro 0.90-1.10 Gly 0.90-1.10 leu 0.90-1.10 Ile 0.90-1.10 Tyr 0.90-1.10 Half-cys 0.90-1.10 |
Conforms Conforms Conforms Conforms Conforms Conforms Conforms Conforms |
|
6.0-10% |
6.9% |
|
≤300IU/mg |
Conforms |
8. total bacterial count |
NMT 100CFU/g |
<10CFU/g |
Assay(HPLC) |
93.0-102.0% On powder≥80.0% Potency≥480iu/mg |
98.5% 86.8% 500iu/mg |
Conclusion: It conforms to EP6.0 Store: at temperature of 2°C to 8°C |
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