| Customization: | Available |
|---|---|
| CAS No.: | 9087-70-1 |
| Formula: | C284h432n84o78r2s7 |
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| ITEMS | SPECIFICATIONS | RESULTS |
| Appearance | Almost white powder, hygroscopic | Conform |
| Solubility | Soluble in water and in isotonic solutions , practically insoluble in organic solvents | Conform |
| Identification A | Positive | Conform |
| Identification B | Positive | Conform |
| Appearance of solution | Solution is clear (15 P.E.U/ml) | Conform |
| Absorbance | A ≤ 0.80 ( 277nm , 3.0 P.E.U. / ml) | 0.72 |
| Aprotinin oligomers | ≤1.0% | 0.58% |
| Loss on drying | ≤ 6.0 % (0.100 g , drying in vacuo) | 4.8% |
| Activity | ≥3.0 Ph. Eur. U./mg | 3.56EPU / mg (6408 KIU / mg) |
| PH | 5.5-7.0 | 6.01 |
| Bacterial endotoxins | ≤ 0.14 EU/ Ph.Eur.U. | Conform |
| Abnormal toxicity | Non toxic (2 Ph.Eur.U. / ml , 0.5 ml) | Conform |
| Pyrogens | Absent at 15Ph.Eur.U./ kg / rabbit | Conform |
| Microbial Limit | TAMC : ≤ 100 CFU/1g TYMC : ≤ 10 CFU/1g |
Conform |
| Conclusion | Comply to EP Current Version | |
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