Pancreatin
- Brands： 药品/原材料
- Model：
- Description：
CAS: 8049-47-6
Source
Porcine pancreas
Characteristic
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（Test with Methods of European Pharmacopoeia and U.S. Pharmacopeia）
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Items |
Company Quality Level |
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EP Standard |
USP Standard |
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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 content |
≤3.0% |
≤3.0% |
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Loss on drying |
≤5.0% 670Pa 60℃,4h |
≤5.0% 670Pa60℃,4h |
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Organic solvent impurities |
≤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 viable aerobic count |
≤8000 cfu/g |
≤8000 cfu/g |
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fungi |
≤80 cfu/g |
≤80 cfu/g |
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Enterobacteria and other G- bacteria |
≤80 cfu/g |
≤80 cfu/g |
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Staphylococcus aureus |
Conforms |
Conforms |
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E. coil |
Conforms |
Conforms |
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Salmonella |
Conforms |
Conforms |
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Storage
Store in an airtight container at 15～25℃.
