China Kallidinogenase of Deebio for Variety of Cardiovascular and Cerebovascular Disease factory and manufacturers

Kallidinogenase of Deebio for Variety of Cardiovascular and Cerebovascular Disease

CAS NO.: 9001-01-8

HS CODE: 3507.9090.90

File Service: Chinese-GMP、DMF

Pharmacopoeia standard: JP/CP

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Product Detail

Product Tags

Detail

1. Characters: White or almost white powder, odourless.

2. Extraction Source: Porcine pancreas.

3. Process: Kallidinogenase is extracted from healthy porcine pancreas.

4. Indications and uses:This product can be used for a variety of cardiovascular and cerebovascular disease, such as coronary heart disease, cerebral arteriosclerosis, cerebral thrombosis, retinal blood supply disorders and peripheral vascular disease. Have a better therapeutic effect on recent researches for thr prevention of early diabetic microangiopathy and diabetic nephropathy, can reduce the albumin excretion. Clinical data both at home and abroad suggest that it can increase sperm activity and production quantity, and has certain curative effect in the treatment of some male sterility.

Why us？

·Produced in GMP workshop

·27 years of biological enzyme R&D history

·Raw materials are traceable

·Comply with customer standard

·Export to over 30 countries and regions

·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.

Specification

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)	————
	Purity	≥ 90% (for injection)	————
	Bacterial endotoxin	≤ 2.5 EU/unit (for injection)	————
Assay	Enzyme activity	————	≥ 25 unit/mg
	Specific activity	≥ 300 unit/mg protein (for oral)	≥ 100 unit/mg protein
	Specific activity	≥ 600 unit/mg protein (for injection)	≥ 100 unit/mg protein
Microbial Impurities	TAMC	≤ 1000cfu/g (for oral)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (for injection)	≤ 1000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Conforms	Conforms
	Salmonella	Conforms	Conforms