Customization: | Available |
---|---|
CAS No.: | 9087-70-1 |
Formula: | C284h432n84o78r2s7 |
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Items | Requirements | Result |
Appearance | Almost white powder, hygroscopic. | Conform |
Solubility | Soluble in water and 0.9% NaCI solution practically insoluble in organic solvents. | Conform |
Appearance of solution | Clear | Conform |
Absorbance | A≤0.80(absoption-max: 277nm±2nm) | 0.60 |
Aprotinin oligomers | ≤1.0% | 0.2% |
Identification | A: Positive | Conform |
B: Positive | Conform | |
Pyroglutamyl-aprotinin and related compounds |
Pyroglutamyl-aprotinin max. 1.0%
|
0.3% |
Any other impurity max. 0.5%
|
0.1% | |
Sum of impurity other than pyroglutamyl-aprotinin max. 1.0%
|
0.2% | |
Activity | ≥3.0Ph.Eur.U./mg | 3.60EPU/mg(6160KIU/mg) |
Bacterial endotoxins | ≤0.14EU/Ph.Eur.U. | Conform |
Abnormal toxicity | Non toxic(2 Ph.Eur.U./ml,0.5ml) | Conform |
Histamine | 0.2ug histamine bas/3 Ph.Eu.U | Conform |
Loss on drying | ≤6.0% | 5.7% |
Microbial Limit | TAMC & TYMC:≤102 in total CFU/g | Conform |
Conclusion | Comply to EP 9.0 |