| Customization: | Available |
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| Certification: | QS, GMP |
| Shape: | Powder |
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| 1.Product information It can inhibit trypsin, chymotrypsin and fibrinolytic enzyme. Our country began to produce in 1968. BP(1988) and Japanese Drug Administration's foreign pharmaceutical ingredient Specification (1985) were collected. It is clinically used for fibrinolysis, acute pancreatitis and pancreatic necrosis. However, it is contraindicated in the case of excessive clotting or lack of enzymes. Similar foreign products include Trasylol (West Germany Bayer), Iniprol (France choag) and Ten Kou Yuji > liquid (Japan). This product is a small molecular protein, composed of 58 amino acids. Its primary and secondary structures have been clarified. Its active center is lysine, which is located at the top of the molecule, with the formula C284H432N8407S7. Molecular weight 6511.47, isoelectric point pH10.5, sedimentation coefficient S2,W= 0.91-1.0s, maximum absorption at 277m wavelength. This product is stable and can be kept in normal saline for more than one year. Stable in neutral or acidic medium at high temperature. In strong alkali (pH>12) medium, the molecular structure changes irreversibly. 2. List of potential animal sources? Health the quarantine inspection cattle lung or fresh frozen cattle lung. 3. How is it made? The expiration date of the product? Raw skin enzymes through melting suppression, extraction, inactivated virus, degeneration, centrifugal separation, ceramic composite membrane, membrane filtration desalination, chromatography technology, purification, remove polymer, pyrogen, freeze drying, inside the bag, outsourcing, and put in storage. 4.Protein content? Conforms to the Chinese pharmacopoeia 2020 edition, conforms to the European pharmacopoeia standards. 5. Enzyme activity? " Chinese pharmacopoeia" 2020 version or skin enzyme raw material quality standards, [titer determination] calculated on anhydride contain antimicrobial skin enzyme > = 3.0 unit/mg, the products can reach more than 6200 kiu/mg and calculated on anhydride contain antimicrobial skin enzyme > = 3.4 unit/mg.
6.The purity determination method?
According to "Chinese pharmacopoeia" 2020 edition or skin enzyme raw material quality standards, the European pharmacopoeia or skin quality standard method for determination of enzyme raw materials |
| 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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