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.
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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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