Pancreatin


CAS NO. : 8049-47-6

Pharmacopoeia standard :CP / EP / USP

HS CODE : 3507.9090.90

File service :Chinese GMP / DMF / EU-DMF


Source:Porcine pancreas.

Characters:Pancreatin is a slightly brown, amorphous powder or slightly brown to cream-coloured granule. It contains various enzymes having protease, lipase and amylase.

Process:Pancreatin is extracted from healthy porcine pancreas by our exclusive activation-extraction technology.



Product details



Test Items


Company Specification

CP

EP

USP

Characters

Powder

A slightly brown, amorphous powder

A slightly brown, amorphous powder

A slightly brown, amorphous powder

Granule

A slightly brown to cream-coloured granule

A slightly brown to cream-coloured granule

A slightly brown to cream-coloured granule

Identification

————

Conforms

————

Tests

Fat content

≤20mg/g

≤ 5.0%

≤3.0%(<3USP);≤ 6.0%(≥3USP)

Loss on drying

≤5.0% 105℃, 4h

≤ 5.0% 670Pa 60℃, 4h

≤ 5.0%Dry in Vacuum 60℃, 4h

Residual solvent

————

≤ 0.5%According to EP(5.4)

≤ 0.5%According to USP(467)

Particle size

————

According to EP(2.1.4&2.9.12)

According to USP(811)

Assay

Protease

≥600U/g

1.0~5.2Ph.Eur.U/mg

100~450USP.U/mg

Amylase

≥7000U/g

12.0~80.0Ph.Eur.U/mg

100~500USP.U/mg

Lipase

≥4000U/g

15.0~130Ph.Eur.U/mg

10~90USP.U/mg

Microbial Impurities

TAMC

≤ 10000cfu/g

≤ 10000cfu/g

≤ 10000cfu/g

TYMC

≤ 100cfu/g

≤ 100cfu/g

≤ 100cfu/g

E.coli

Conforms

Conforms

Conforms

Salmonella

Conforms

Conforms

Conforms




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