CAS No.: 9001-01-8
Complies with CP2020,?JP18
Kallidinogenase |
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Source | Porcine pancreas | ||||
Process description | Kallidinogenase is an enzyme extracted from healthy porcine pancreas, and has kinin-releasing activity based on cleavage of kininogen. It contains not less than 300 kallidinogenase units(for oral use) or 600 kallidinogenase units(for injection use) per mg | ||||
Productionrequirements | This product should be extracted from porcine pancreas that has passed quarantine. Production process should conform with the requirements of current version of Good Manufacturing Practice. This product is derived from animals, and appropriate virus inactivation processes should be used for virus safety control during production | ||||
Pharmacopoeia standard |
CP |
JP |
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for oral |
for injection |
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Character |
White or almost white powder. Odorless.It is freely soluble in water, and practically insoluble in ethanol and diethyl ether. | Description Kallidinogenase occurs as a white to light brown powder. It is odorless or has a faint, characteristic It is freely soluble in water, and practically insoluble in ethanol (95) and in diethyl ether. | |||
Identification |
The value of R?should be 0.12~0.17 | The value of R does not exceed 0.2 | |||
The retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution | the value of R is between 0.12~0.16 | ||||
Test |
pH | 5.5-7.5 | 5.5-7.5 | ||
Appearance of solution | Should be clear | _______ | |||
Purity | ≥70% | ≥90% | _______ | ||
Purity | Fat | The mass of residue is not more than 5mg | The mass of residue is not more than 1mg | ||
Kininase | _______ | The value R is not less than 0.8 | |||
Trypsin-like substance | _______ | The value of T does not exceed 0.05 | |||
Protease | A280≤0.2 | The value of (A-A0) not more than 0.2 | |||
Loss on drying | ≤5.0% | Not more than 2.0% | |||
Residue on ignition | ≤3.0% | Not more than 3% | |||
Bacterial endotoxin | / | ≤2.5 EU/IU(for injection) | _______ | ||
Kinin-releasing activity | _______ | Not less than 500ng bradykinin equivalent/minute/unit | |||
Total protein | Conform with regulation | _______ | |||
Potency |
Enzyme activity | Conform with regulation | Not less than 25IU/mg | ||
Specific activity | ≥300IU/mg.pr | ≥?600IU/mg.pr | Not less than 100IU/mg.pr | ||
Microbial limit |
TAMC | ≤1000cfu/g | ≤1000cfu/g | ||
TYMC | ≤100cfu/g | ≤100cfu/g | |||
Escherichia coli | Should not be detected per g | Should not be detected per g | |||
Salmonella | Should not be detected per 10g | Should not be detected per 10g | |||
Storage |
Protected from light, sealed, stored in a cool, dry place. | Tight containers | |||
Category |
Vasodilators. | ||||
Preparation |
Kallidinogeanse?enteric-coated tablets |