| Certification: | QS, GMP |
|---|---|
| Shape: | Powder |
| Function: | Inhibit Trypsin, Chymotrypsin and Fibrinolytic En |
| Type: | Trypsin |
| Transport Package: | Depend on Customer Request |
| Specification: | 100g /500g |
| Samples: |
|---|
| Customization: |
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Aprotinin CAS NO: 9087-70-1 Aprotinase, also known as Bovine pancreatic trypsin inhibitor BPTI, Kallikrein inhibitor, etc. Its molecular formula is C284H432N84O79S7, which is a basic polypeptide chain containing 58 amino acid residues. Its molecular weight is 6.5KD(6511.44), and its isoelectric point is 10.5. Aprotinin is an inhibitor of serine protease, and its preparation is mainly used for the treatment and prevention of pancreatitis; For the treatment of acute bleeding; For antishock; It is used to prevent intestinal adhesion. This product is extracted from the lung of yellow cattle. The crude product of aprotinin is obtained by acid water extraction and ammonium sulfate precipitation. The crude product then goes through acid precipitation, filtration, chromatography purification, sterilization and freeze-drying to obtain aprotinin freeze-dried powder products. |
| Test Items | Specifications | Results |
| 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;3.0 Ph.Eur.U./ml) | 0.76 |
| Identification A | Positive | Conform |
| Identification B | Positive | Conform |
| Aprotinin oligomers | Maximum1.0% | 0.3% |
| Pyroglutamyl-aprotinin and related compounds |
Pyroglutamyl-aprotinin max.1.0% | 0.03% |
| Any other impurity max. 0.5% | 0.3% | |
| Sum of impurity other than pyroglutamyl-aprotinin max.1.0% | 0.5% | |
| Des-Ala-Aprotinin And des-Ala-des-Gly-aprotinin | impurity A:maximum 8.0 per cent | 6.38% |
| impurity B:maximum 7.5 per cent |
6.98% | |
| pH | 5.5-7.0 | 6.2 |
| Loss on drying | ≤6.0% | 5.5% |
| Bacterial endotoxins | ≤ 0.14 EU / Ph.Eur.U. | Conform |
| Abnormal toxicity | Non toxic at 2 Ph.Eur.U. / 0.5ml | Conform |
| Histamine | 0.2ug histamine base/3 Ph.Eur.U. | Conform |
| Microbial Limit | TAMC And TYMC :≤102 in total CFU/g API | Conform |
| Staphylococcus aureus, Pseudomonas areuginsosa, Escherichia coli, should be absent per 1 g(ml), Entrobacteria, resistant to bile, should be absent per 1 g(ml) | Conform | |
| Activity | ≥3.0 Ph.Eur.U./mg | 3.67EPU/m (6620KIU/mg) |
| Conclusion | Comply with EP 9.0 | |
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