Description

Pancrelipase is a potent enzyme preparation derived from porcine pancreas, standardized for its lipase, protease, and amylase activity. It is a critical pharmaceutical active ingredient essential for the treatment of exocrine pancreatic insufficiency, aiding in the digestion of fats, proteins, and carbohydrates. This high-purity product is primarily utilized by pharmaceutical manufacturers in the production of enzyme replacement therapies and digestive aid formulations.

Application

• Pharmaceutical Active Ingredient: Core component in prescription medications for pancreatic exocrine insufficiency (EPI) such as pancreatin capsules and tablets.
• Digestive Enzyme Supplements: Used in over-the-counter (OTC) dietary supplements designed to support digestive health.
• Veterinary Medicine: Formulated into digestive aids for companion animals and livestock with pancreatic disorders.
• Research & Development: Serves as a standard or reagent in biochemical research, particularly in studies of lipid metabolism and digestive processes.
• Biocatalyst: Potential application in specialized biocatalytic processes in fine chemical synthesis due to its esterase and protease activities.

Basic Information

Product Name	Pancrelipase
CAS No.	53608-75-6
Molecular Formula	Mixture of Enzymes (Proteins)
Molecular Weight	Variable (Enzyme Mixture)
Synonyms	Pancreatin, Pancreatic Enzymes; Lipase, Protease, and Amylase; Porcine Pancreatic Extract; Trienzyme; USP Pancrelipase; Pancreatic Enzyme Concentrate; PPC (Pancreatic Polypeptide Concentrate); Steapsin (historical).
EINECS	Contact for details

Quality Control

Our Pancrelipase is manufactured and tested to meet stringent pharmacopeial standards. Each batch is validated for enzymatic activity units (Lipase, Protease, Amylase) and undergoes comprehensive testing for identity, purity, and safety. We provide full traceability and support compliance with USP, EP, and cGMP guidelines. A detailed Certificate of Analysis (COA) is available for every shipment upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); protect from humidity and store in the original desiccated packaging. For long-term stability, consider storage at 2-8°C.

Specification

Item	Specification
Description	Light brown to cream-colored powder
Identification (IR)	Conforms
Lipase Activity	Contact for details
Protease Activity	Contact for details
Amylase Activity	Contact for details
Loss on Drying	≤ 5.0%
Microbial Limits	Meets USP/EP requirements
Fat Content	≤ 2.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.