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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
  • 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.

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    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

    CP

    JP

    Characters

    White or almost white powder, odourless

    White to slighty brown powder, odourless or has a faint

    Identification

    R (hydrolysis rate): 0.120.17

    R (hydrolysis rate): 0.120.16

    Liquid Chromatography: Conforms

    I : ≤ 0.2

    Tests

    pH

    5.57.5300unit/ml

    5.57.51g/300ml

    Clarity of solution

    Clear2mg/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

    ————

    ≥ 25 unit/mg

    Specific activity

    ≥ 300 unit/mg protein (for oral)

    ≥ 100 unit/mg protein

    ≥ 600 unit/mg protein (for injection)

    Microbial Impurities

    TAMC

    ≤ 1000cfu/g (for oral)

    ≤ 1000cfu/g

    ≤ 100cfu/g (for injection)

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Conforms

    Conforms

    Salmonella

    Conforms

    Conforms


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