Pancreatin of with Formulation of Powder, Granule and Pellet
Detail
1. Characters: Pancreatin is a slightly brown, amorphous powder or slightly brown to cream-coloured granule. It is composed of amylase, lipase and protease.
2. Extraction Source: Porcine pancreas.
3. process: Pancreatin is extracted from healthy porcine pancreas by our exclusive activation-extraction technology.
4 .Indications and uses: Pancreatin is a mixture of several digestive enzymes produced by the pancreas of porcine. It can be used in the pharmaceutical industry, food processing, tanning, washing and other fields, with a wide range of applications.
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
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Test Items |
Company Specification |
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CP |
EP |
USP |
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Characters |
Powder |
A slightly brown, amorphous powder |
A slightly brown, amorphous powder |
A slightly brown, amorphous powder |
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Granule |
A slightly brown to cream-coloured granule |
A slightly brown to cream-coloured granule |
A slightly brown to cream-coloured granule |
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Identification |
———— |
Conforms |
———— |
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Tests |
Fat content |
≤20mg/g |
≤ 5.0% |
≤3.0%(<3USP)；≤ 6.0%(≥3USP) |
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Loss on drying |
≤5.0% 105℃, 4h |
≤ 5.0% 670Pa 60℃, 4h |
≤ 5.0%Dry in Vacuum 60℃, 4h |
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Residual solvent |
———— |
≤ 0.5%According to EP(5.4) |
≤ 0.5%According to USP(467) |
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Particle size |
———— |
According to EP(2.1.4&2.9.12) |
According to USP(811) |
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Assay |
Protease |
≥600U/g |
1.0～5.2Ph.Eur.U/mg |
100～450USP.U/mg |
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Amylase |
≥7000U/g |
12.0～80.0Ph.Eur.U/mg |
100～500USP.U/mg |
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Lipase |
≥4000U/g |
15.0～130Ph.Eur.U/mg |
10～90USP.U/mg |
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Microbial Impurities |
TAMC |
≤ 10000cfu/g |
≤ 10000cfu/g |
≤ 10000cfu/g |
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TYMC |
≤ 100cfu/g |
≤ 100cfu/g |
≤ 100cfu/g |
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E.coli |
Conforms |
Conforms |
Conforms |
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Salmonella |
Conforms |
Conforms |
Conforms |
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