| Powder: | Yes |
|---|---|
| Customized: | Customized |
| Certification: | GMP, HSE, ISO 9001, USP, BP |
| Suitable for: | Elderly, Adult |
| State: | Yellow-Brown |
| Purity: | >99% |
| Samples: |
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| Customization: |
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Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, and protease.They are used to treat malabsorption syndrome due to certain pancreatic problems.These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, pancreatic cancer, or MODY 5, among others.The preparation is taken by mouth.
Common side effects include vomiting, abdominal pain, constipation, and diarrhea.Other side effects include perianal irritation and high blood uric acid.The enzymes are from pigs.Use is believed to be safe during pregnancy.The components are digestive enzymes similar to those normally produced by the human pancreas.They help the person digest fats, starches, and proteins.
Pancreatic enzymes have been used as medications since at least the 1800s. They are on the World Health Organization's List of Essential Medicines.In 2020, it was the 262nd most commonly prescribed medication in the United States, with more than 1 million prescriptions.
PRODUCT 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 disbetes.
Brief Introduction of Production.
Pancreatin is extracted from porcine pancreas by our exclusive extraction skill.
Specification(Test with Method of the United States Pharmacopoeia)
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> |
| Irradiation | No Irradiation | |
| GMO | Product No-GMO (Reg.1829/2003-1830/2003 EC) | |
| Allergens | Non allergen, in compliance with Reg.1169/2011 Annex II | |
| BSE/TSE | Free | |
| Melamine | Free, No melamine(Reg.EU 594/2012) | |
| Ethylen-oxide | No Ethylen-oixde | |
| Packing | Pack in paper-drums and two plastic-bags inside N.W. 25 kgs I.D.35xH51cm. | |
| Storage | Store in a well-closed container away from moisture, light, oxygen. | |
| Shelf Life | 24 months under the conditions above and in its original packaging | |
| Name | CAS No. |
| α-Amylase | 9000-90-2 |
| Bromelain | 9001-00-7 |
| Glucose oxidase | 9001-37-0 |
| Lactase | 9031-11-2 |
| Lipase | 9001-62-1 |
| Lysozyme | 12650-88-3 |
| Papain | 9001-73-4 |
| Pepsin | 9001-75-6 |
| Pancreatin | 8049-47-6 |
| Trypsin | 9002-07-7 |
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