Pancreatin
Pancreatin Powder Manufacturer | Multi-Enzyme Digestive Complex Headline: Premium Pancreatin Powder Manufacturer | High Activity Digestive Complex (CAS: 8049-47-6) Sub-headline: 4X / 8X USP Grade | Amylase, Lipase, Protease Triple Action | Porcine Origin Unique Selling Proposition (USP): • Triple Enzyme Power: Contains a standardized ratio of Lipase (fat digestion), Protease (protein digestion), and Amylase (starch digestion). • High Potency Options: Available in USP activity levels from 1X to 8X to meet various formulation strengths. • Low Bioburden: Processed under strict sanitary conditions to ensure microbiological safety.
Introduction
Pancreatin (CAS: 8049-47-6) is a substance containing enzymes, principally amylase, lipase, and protease, obtained from the pancreas of the hog, Sus scrofa.
It is an off-white to yellowish powder with a characteristic, slight odor. Pancreatin is the cornerstone of Exocrine Pancreatic Insufficiency (EPI) treatment, helping patients suffering from conditions like Cystic Fibrosis or Pancreatitis to properly digest and absorb nutrients. Unlike single enzymes, Pancreatin provides a full-spectrum digestive solution that mimics the body's natural function.
Category：
Keywords：
pancreatin
digestive
Functions
1.Fat Digestion (Lipase Activity)
• Mechanism: Hydrolyzes triglycerides into fatty acids and glycerol.
• Action: Critical for preventing steatorrhea (fatty stools) and ensuring the absorption of fat-soluble vitamins (A, D, E, K).
2.Protein Digestion (Protease Activity)
• Mechanism: Cleaves peptide bonds in proteins to form oligopeptides and amino acids.
• Action: Enhances nitrogen retention and muscle maintenance in patients with compromised digestion.
3.Carbohydrate Digestion (Amylase Activity)
• Mechanism: Breaks down starch and glycogen into dextrins and maltose.
• Action: Prevents bloating and gas caused by undigested carbohydrates fermenting in the gut.
Applications
1.Pharmaceutical Enteric-Coated Tablets
• Application: Treatment of Exocrine Pancreatic Insufficiency (EPI).
• Why it works: Formulated with enteric coating to bypass stomach acid (which deactivates enzymes) and release in the alkaline environment of the small intestine.
2.Digestive Aid Supplements
• Application: Multi-enzyme blends for general digestive health.
• Why it works: Supports digestion after heavy meals, reducing post-prandial discomfort.
3.Industrial & Leather Use
• Application: Leather bating and desizing of textiles.
• Why it works: Its proteolytic activity softens leather hides effectively.
Flow Chart
1.Gland Collection: Fresh porcine pancreas glands collected from inspected facilities.
2.Activation: Grinding and activation of enzymes.
3.Defatting: Removal of lipids using organic solvents (acetone/alcohol) to prevent rancidity.
4.Extraction: Aqueous or solvent extraction of the active enzymes.
5.Concentration: Vacuum concentration.
6.Precipitation: Salt or solvent precipitation.
7.Drying: Low-temperature vacuum drying to preserve enzyme activity.
8.Standardization: Blending with lactose/sucrose to achieve specific USP units (e.g., 4X).
9.Packaging: 25kg Drums.
Quality Standard of Lactoferrin
Product: Pancreatin 4X USP
CAS: 8049-47-6
| Item | Specification | Result |
| Appearance | White to yellowish powder | Conforms |
| Amylase Activity | ≥ 100 USP Units/mg (4X) | 110 USP Units/mg |
| Lipase Activity | ≥ 8 USP Units/mg (4X) | 9.5 USP Units/mg |
| Protease Activity | ≥ 100 USP Units/mg (4X) | 108 USP Units/mg |
| Fat | ≤ 3.0% | 1.2% |
| Loss on Drying | ≤ 5.0% | 3.5% |
| Salmonella | Negative | Negative |
| E. Coli | Negative | Negative |
(Note: "4X" means the activity is 4 times the minimum USP standard for Pancreatin)
Method of Analysis of Lactoferrin
Test Method: USP Monograph Methods
• Amylase: Starch iodine method.
• Lipase: Olive oil titration method (pH stat).
• Protease: Casein digestion method.
• Verification: Each enzyme activity is tested independently to ensure the "Triple Action" claim is met.
Reference Chromatogram of Lactoferrin Reference Substance
(Note: As a complex mixture, potency is determined by Activity Assays, not HPLC)
Electrophoresis (SDS-PAGE) can be used to visualize the distinct bands of amylase, lipase, and protease proteins, ensuring the integrity of the extract.
Stability and Safety
Stability Studies
• Moisture Sensitivity: Highly Hygroscopic. Moisture causes rapid loss of activity.
• Thermostability: Unstable at high temperatures (>40°C).
• Shelf Life: 24 Months when stored in tightly closed containers at temperatures below 25°C. Desiccants are recommended.
Safety & Handling (MSDS Summary)
• Classification: Sensitizer (Enzyme).
• Handling: Do not inhale dust. Use exhaust ventilation and wear a dust mask. Repeated inhalation can cause asthma-like symptoms.
• Storage: Store in a cool, dry place.
Customer Comments
R&D Manager, PharmaGastro (Germany)
2026.03.05
★★★★☆
Production Lead, NutraTablets (USA)
2026.03.05
★★★★☆
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FAQ
Is Pancreatin Halal or Kosher?
Most commercial Pancreatin is Porcine (Pig) derived because pig pancreas enzymes are most similar to humans. Therefore, it is generally NOT Halal or Kosher. Bovine options exist but have lower lipase activity.
What is the difference between 1X and 4X?
1X meets the minimum USP activity. 4X means it is concentrated to be four times as potent per milligram. 4X is the industry standard for high-potency supplements to reduce pill size.
Does it need enteric coating?
Yes, if used for therapeutic purposes. Stomach acid (pH 1-3) denatures lipase and amylase. Enteric coating protects the enzymes until they reach the duodenum (pH 6-8) where they are needed.
References
1.Fieker, A., et al. (2011). "Enzyme replacement therapy for pancreatic insufficiency: present and future." Clinical and Experimental Gastroenterology.
2.United States Pharmacopeia (USP) Monograph: Pancreatin.
3.Layer, P., et al. (2011). "Pancreatic enzyme replacement therapy." Current Gastroenterology Reports.
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