We’ve been proud of your substantial purchaser satisfaction and wide acceptance due to our persistent pursuit of high quality both equally on solution and service for OEM Factory for Pancreatin Ec Pellets (10, 000 Units; 25, 000 Units) Pellets (for capsules), We hope to establish far more organization associations with consumers all over the globe.
We’ve been proud of your substantial purchaser satisfaction and wide acceptance due to our persistent pursuit of high quality both equally on solution and service for China Pancreatin and Medicine, We’ll continue to devote ourselves to market & product development and build a well-knit service to our customer to create a more prosperous future. Remember to contact us today to find out how we can work together.
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.
·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.
Test Items |
Company Specification |
|||
CP |
EP |
USP |
||
Characters |
Powder |
A slightly brown, amorphous powder |
A slightly brown, amorphous powder |
A slightly brown, amorphous powder |
Granule |
A slightly brown to cream-coloured granule |
A slightly brown to cream-coloured granule |
A slightly brown to cream-coloured granule |
|
Identification |
———— |
Conforms |
———— |
|
Tests |
Fat content |
≤20mg/g |
≤ 5.0% |
≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Loss on drying |
≤5.0% 105℃, 4h |
≤ 5.0% 670Pa 60℃, 4h |
≤ 5.0%Dry in Vacuum 60℃, 4h |
|
Residual solvent |
———— |
≤ 0.5%According to EP(5.4) |
≤ 0.5%According to USP(467) |
|
Particle size |
———— |
According to EP(2.1.4&2.9.12) |
According to USP(811) |
|
Assay |
Protease |
≥600U/g |
1.0~5.2Ph.Eur.U/mg |
100~450USP.U/mg |
Amylase |
≥7000U/g |
12.0~80.0Ph.Eur.U/mg |
100~500USP.U/mg |
|
Lipase |
≥4000U/g |
15.0~130Ph.Eur.U/mg |
10~90USP.U/mg |
|
Microbial Impurities |
TAMC |
≤ 10000cfu/g |
≤ 10000cfu/g |
≤ 10000cfu/g |
TYMC |
≤ 100cfu/g |
≤ 100cfu/g |
≤ 100cfu/g |
|
E.coli |
Conforms |
Conforms |
Conforms |
|
Salmonella |
Conforms |
Conforms |
Conforms |
We’ve been proud of your substantial purchaser satisfaction and wide acceptance due to our persistent pursuit of high quality both equally on solution and service for OEM Factory for Pancreatin Ec Pellets (10, 000 Units; 25, 000 Units) Pellets (for capsules), We hope to establish far more organization associations with consumers all over the globe.
OEM Factory for China Pancreatin and Medicine, We’ll continue to devote ourselves to market & product development and build a well-knit service to our customer to create a more prosperous future. Remember to contact us today to find out how we can work together.