Kallidinogenase
CAS No.: 9001-01-8 (kinin-releasing activity)

Kallidinogenase

Source

Porcine pancreas

Process description

Kallidinogenase is an enzyme extracted from healthy porcine pancreas, and has kinin-releasing activity based on cleavage of kininogen.

Production

requirements

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

for oral

for injection

Character

White or almost white powder. Odorless.

It is freely soluble in water, and practically insoluble in ethanol and diethyl ether.

A white to light brown powder. It is odorless or has a faint, characteristic odor.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 I 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 and 0.16

Test

pH

5.5-7.5

5.5-7.5

Appearance of solution

_______

Should be clear

_______

Purity

≥75%

≥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

Not more than 5.0%

Not more than 2.0%

Residue on ignition

Not more than 3.0%

Not more than 3%

Bacterial endotoxin

_______

≤2.5 EU/IU

_______

Kinin-releasing activity

_______

Not less than 500ng bradykinin equivalent/minute/unit

Potency

Activity

_______

Not less than 25IU/mg

Specific activity

≥300IU/mg.pr

≥ 600IU/mg.pr

Not less than 100IU/mg.pr

Microbial limit

TAMC

≤10³cfu/g

TYMC

≤10²cfu/g

Escherichia coli

Should not be detected per g

Salmonella

Should not be detected per 10g

Storage

Store in an airtight container, protected from

 light of temperature below 20℃

Tight containers

Category

Vasodilators.

Preparation

Kallidinogenase enteric-coated tablets