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Pancreatin

Source:Porcine pancreas.

Characters:Pancreatin is a slightly brown, amorphous powder or slightly brown to cream-coloured granule. It contains various enzymes having proteolytic, lipolytic and amylolytic activities.

Function:Pancreatin is used to cure indigestion, loss of appetite, dysfunction of digestive system caused by liver or pancreatic gland disease and indigestion caused by diabetes.

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


Powder   A slightly brown, amorphous powder

Granule   A slightly brown to cream-coloured granule

——————————————————

Fat content≤ 5.0%

Loss on drying≤ 5.0% 670Pa 60℃, 4h

Residual solvent≤ 5.0%According to EP(5.4)

Particle sizeAccording to EP(2.1.4&2.9.12)

——————————————————

Protease1.0~5.2Ph.Eur.U/mg

Amylase12.0~80.0Ph.Eur.U/mg

Lipase15.0~130Ph.Eur.U/mg

——————————————————

TAMC≤ 10000cfu/g

TYMC≤ 100cfu/g

E. coliConforms

SalmonellaConforms





Powder   A slightly brown, amorphous powder

Granule   A slightly brown to cream-coloured granule

——————————————————

Fat content≤ 3.0%

Loss on drying≤5.0% 700Pa60℃,4h

Residual solvent :≤ 5.0%According to BP

Particle size :According to BP

——————————————————

Protease1.4~5.2Ph.Eur.U./mg

Amylase20~65.0Ph.Eur.U./mg

Lipase24~110Ph.Eur.U./mg

——————————————————

TAMC≤ 10000cfu/g

TYMC≤ 100cfu/g

E. coliConforms

SalmonellaConforms





Powder   A slightly brown, amorphous powder

Granule   A slightly brown to cream-coloured granule

——————————————————

Fat content≤20mg/g

Loss on drying≤5.0% 105℃, 4h

Residual solvent————

Particle size————

——————————————————

Protease≥600U/g

Amylase≥7000U/g

Lipase≥4000U/g

——————————————————

TAMC≤ 10000cfu/g

TYMC≤ 100cfu/g

E. coliConforms

SalmonellaConforms





Powder   A slightly brown, amorphous powder

Granule   A slightly brown to cream-coloured granule

——————————————————

Fat content≤ 3.0%(<3USP);≤ 6.0%(≥3USP)

Loss on drying≤ 5.0%Dry in Vacuum 60℃, 4h

Residual solvent≤ 5.0%According to USP(467)

Particle sizeAccording to USP(811)

——————————————————

Protease100~450USP.U/mg

Amylase100~500USP.U/mg

Lipase10~90USP.U/mg

——————————————————

TAMC≤ 10000cfu/g

TYMC≤ 100cfu/g

E. coliConforms

SalmonellaConforms



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