Pancreatin is a digestive enzyme complex containing amylase, lipase, and protease, designed to aid the digestion of carbohydrates, fats, and proteins.
It is widely used in pharmaceutical formulations for the management of exocrine pancreatic insufficiency (EPI) and in nutraceutical digestive aid supplements to support gastrointestinal health.
1. PRODUCT IDENTIFICATION
| Enzyme Name | Pancreatin |
| Synonyms | Pancreatic Enzyme Complex |
| Enzyme Components | Amylase, Lipase, Protease |
2. PRODUCT DESCRIPTION
Pancreatin supports the digestion of carbohydrates, fats, and proteins and is commonly used in enzyme replacement therapy and digestive health supplements.
3. GRADE
- Pharmaceutical Grade (USP / IP / BP)
- Nutraceutical Grade
(Grade supplied as per customer requirement.)
4. AVAILABLE FORM
A white or buff-coloured amorphous powder
5. TECHNICAL SPECIFICATIONS
| Description | A white or buff-coloured amorphous powder |
| Identification | Conforms |
| Amylase Activity | As per USP / IP |
| Lipase Activity | As per USP / IP |
| Protease Activity | As per USP / IP |
| Loss on Drying | ≤ 5.0% |
(Enzyme activities and specifications can be customized as per pharmacopeial or formulation needs.)
6. ENZYMATIC PROPERTIES
- Optimal pH:
- Amylase: 6.7 – 7.0
- Lipase: 7.5 – 8.5
- Protease: 7.0 – 9.0
- Optimal Temperature: 35°C – 40°C
- Solubility: Practically insoluble in water; dispersible
7. APPLICATIONS
Pharmaceuticals- Pancreatic enzyme replacement therapy (PERT)
- Digestive disorder management
- Digestive enzyme supplements
- GI health and nutrient absorption support
8. REGULATORY & COMPLIANCE
- Manufactured in GMP-certified facilities
- Complies with USP / IP / BP
- BSE/TSE Controlled (with supporting documentation)
- Allergen Information: Derived from porcine source
Documents Available:
- Certificate of Analysis (CoA)
- MSDS / SDS
- Stability data
- TSE/BSE statement
9. PACKAGING
- 5 kg / 10 kg / 25 kg HDPE drum with double LDPE liner
- Custom packaging available on request
10. STORAGE & SHELF LIFE
- Store in a cool, dry place, protected from heat and moisture
- Keep container tightly closed
- Shelf Life: 24–36 months under recommended storage conditions
11. SAFETY INFORMATION
- For industrial and formulation use only
- Avoid inhalation of enzyme dust
- Use appropriate PPE
- Refer to MSDS for detailed safety and handling instructions
12. COMMERCIAL INFORMATION
- MOQ: As per activity and packaging
- Lead Time: 7 Days
- Supply Capability: Bulk and contract supply
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