| Certification: | ISO, FDA, HACCP |
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| Assay Method: | HPLC |
| Application Form: | Paste, Tablet, Capsule |
| Application: | Food, Health Care Products |
| State: | Powder |
| Extract Source: | Porcine Pancereas Glands |
| Samples: |
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| Customization: |
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Product Name: Pancreatin
Appearance: White to ceamy fine powder
Specification: 4XUSP, 6XUSP
Pancreatic enzymes also known as pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, and protease. They are used to treat malabsorption syndrome due to pancreatic problems. These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, or pancreatic cancer among others. It is taken by mouth.
TECHNICAL DATE SHEET
| PRODUCT SPECIFICATIONS | ||
| Product Name: | Pancreatin | |
| Source | Porcine pancereas glands | |
| ANALYSIS ITEMS | SPECIFICATION | TEST METHOD |
| Appearance | Fine powder | Organoleptic |
| Color | White to ceamy | Visual |
| Odour & Taste | Characteristic odour and taste no putrid smell | Organoleptic |
| Identification | Identical to R.S. sample | HPTLC |
| Protease | NLT 150 USP u/mg | |
| Amylase | NLT 150 USP u/mg | |
| Lipase | NLT 12 USP u/mg | |
| Solubility | Partly soluble in water | |
| Sieve Analysis | 100% through 80 mesh | USP39 <786> |
| Loss on drying | ≤ 5.0% | Eur.Ph.9.0 [2.5.12] |
| Fat content | ≤ 20mg/g | |
| Aerobic bacteria(TAMC) | ≤10000 cfu/g | USP39 <61> |
| Yeast/Moulds(TAMC) | ≤100 cfu/g | USP39 <61> |
| Bile-tol.gram- b./Enterobact.: | ≤100 cfu/g | |
| Escherichia coli: | Absent in 1g | USP39 <62> |
| Salmonella: | Absent in 25g | USP39 <62> |
| Staphylococcus aureus: | Absent in 1g | |
| Aflatoxins B1 | ≤ 5 ppb -Reg.EC 1881/2006 | USP39 <62> |
| Aflatoxins ∑ B1, B2, G1, G2 | ≤ 10 ppb -Reg.EC 1881/2006 | USP39 <62> |
Pancreatin is used to cure indigestion, loss of appetite,dysfunction of digestive system caused by liver or pancreatic gland disease and indigestion caused by disbetes.
Brief Introduction of Production
Pancreatin is extracted from porcine pancreas by our exclusive extraction skil.
Specification(Test with Method of the United States Pharmacopoeia)
Application:
Pancreatin is used to cure indigestion, loss of appetite,dysfunction of digestive system caused by liver or pancreatic gland disease and indigestion caused by disbetes.
Usage
Pancreatin is a digestive enzyme that is used to supplement weight loss of or low digestive enzymes, often used in people with cystic fibrosis. Its synonyms include: Pancreatinum and Pancreatic Enzymes. It has also been claimed to help with food allergies, celiac disease, autoimmune disease, cancer, and weight loss
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