Kallidinogenase

CAS NO. :9001-01-8	Pharmacopoeia standard ：CP / JP
HS CODE :3507.9090.90	File service ：Chinese GMP / DMF

Source：Procine pancreas.

Characters：White or almost white powder, odourless.

Process：Kallidinogenase is extracted from healthy procine pancreas.

Test Items		Company Specification
Test Items		CP	JP
Characters		White or almost white powder,odourless	White to slighty brown powder,odourless or has a faint
Identification		R (hydrolysis rate): 0.12～0.17	R (hydrolysis rate): 0.12～0.16
Identification		Liquid Chromatography: Conforms	I : ≤ 0.2
Tests	pH	5.5～7.5（300unit/ml）	5.5～7.5（1g/300ml）
	Clarity of solution	Clear（2mg/ml）	————
	Fat	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Value：≥ 0.8
	Trypsin-like substance	————	T Value：≤ 0.05
	Protease	A280≤ 0.2	A280≤ 0.2
	Loss on drying	≤ 5.0% (60℃ Dry in Vacuum, 4h)	≤ 2.0% (60℃ Dry in Vacuum, 4h)
	Residue on ignition	≤ 3.0%	≤ 3.0%
	Kinin-releasing activity	————	≥ 500ng bradykinin equivalent/min/unit per unit
	Purity	≥ 75% (for oral) ≥ 90%(for injection)	————
	Bacterial endotoxin	≤ 2.5 EU/unit (for injection)	————
Assay	Enzyme activity	————	≥ 25unit/mg
Assay	Specific activity	≥ 300unit/mg protein(for oral) ≥ 600unit/mg protein(for injection)	≥ 100unit/mg protein
Microbial Impurities	TAMC	≤ 1000cfu/g (for oral) ≤ 100cfu/g (for injection)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Conforms	Conforms
	Salmonella	Conforms	Conforms

Properties

Pancreatic kallikrein is a kallikrein in human tissues and mammals. It exists in the form of inactive precursor kallikrein in vivo, which can degrade kallikrein into kallikrein. Kinin can expand blood vessels and capillaries, increase vascular permeability, improve microcirculation, regulate blood pressure, and reduce myocardial oxygen consumption.

CAS No.

9001-01-8

Molecular Mass

Exact Mass

0.0

Matter Classification

organic

Category

Appearance

White or yellowish powder, with special smell, easily soluble in water and insoluble in ether; Unstable to heat, acid, alkali and oxidant.

HS Code

35079090