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.
Specification(According to current EP and USP)
Items |
Company Specification |
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EP |
USP |
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Characters |
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 |
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Identification |
Conforms |
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Tests |
Fat |
≤3.0% |
≤3.0% |
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Loss on drying |
≤5.0% 670Pa60℃,4h |
≤5.0% 670Pa60℃,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 |
Total protease |
1.0~5.2Ph.Eur.U./mg |
100~350USP.U/mg |
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Amylase |
12.0~65.0Ph.Eur.U./mg |
100~350USP.U/mg |
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Lipase |
15.0~110Ph.Eur.U./mg |
10~75USP.U/mg |
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Microbial Impurities |
Total bacterial count |
≤10000 cfu/g |
≤10000 cfu/g |
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Moulds and yeasts |
≤100 cfu/g |
≤100 cfu/g |
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E. coli |
Conforms |
Conforms |
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Salmonella |
Conforms |
Conforms |
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Storage
In an airtight container at15℃~25℃.
More details, please contact:Email: info@cosuppliers.com
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