Kallidinogenase


CAS NO. : 9001-01-8

Pharmacopoeia standard :CP / JP

HS CODE : 3507.9090.90

File service :Chinese GMP / DMF


SourceProcine pancreas.

CharactersWhite or almost white powder, odourless.

ProcessKallidinogenase is extracted from healthy procine pancreas.



Product details


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): 0.12~0.17

R (hydrolysis rate): 0.12~0.16

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

————

≥ 25 unit/mg

Specific activity

≥ 300 unit/mg protein (for oral)

≥ 600 unit/mg protein (for injection)

≥ 100 unit/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





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