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