Description

Pancreatin is a vital enzyme preparation derived from porcine or bovine pancreas, containing a mixture of key digestive enzymes including amylase, lipase, and protease. This complex is essential for catalyzing the hydrolysis of starches, fats, and proteins, making it a critical biochemical tool. It is indispensable for pharmaceutical manufacturers, diagnostic kit producers, and research institutions focused on digestive health, biotechnology, and analytical chemistry.

Application

• Pharmaceutical Manufacturing: Core active ingredient in enzyme replacement therapies (e.g., pancrelipase) for conditions like pancreatic insufficiency, cystic fibrosis, and chronic pancreatitis.
• Diagnostic Reagents: Used as a key component in in vitro diagnostic kits for clinical chemistry assays measuring pancreatic function and related biomarkers.
• Biotechnology & Research: Employed in molecular biology for tissue dissociation, protein digestion in proteomics, and as a model enzyme in biochemical studies of digestion and kinetics.
• Food Industry (FCC Grade): Acts as a processing aid for flavor development, texture modification, and as a digestive aid in nutritional supplements.
• Feed Additives: Incorporated into animal feed to enhance nutrient digestibility and improve feed conversion efficiency, particularly for young livestock.

Basic Information

Product Name	Pancreatin
CAS No.	8049-47-6
Molecular Formula	Mixture
Molecular Weight	N/A (Enzyme Mixture)
Synonyms	Pancreatic Enzymes; Pancreatic Extract; Pancreatin Powder; Pankreatin; Pancreatinum; INS 1104(iii); E 1104(iii); 3.2.1.1 (Amylase); 3.1.1.3 (Lipase); 3.4.21.4 (Trypsin)
EINECS	232-468-9

Quality Control

Our Pancreatin is manufactured and tested under strict quality management systems. We offer grades compliant with major pharmacopoeial standards, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia), as well as FCC (Food Chemicals Codex) for food applications. Each batch undergoes rigorous analytical testing for enzymatic activity (amylase, lipase, protease), microbial limits, and identification. A comprehensive Certificate of Analysis (COA) is provided with every shipment to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C for long-term stability. This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent moisture absorption and loss of potency. Keep away from incompatible materials such as strong acids, bases, and oxidizing agents.

Specification

Item	Specification
Description	Light brown to cream-colored powder
Identification (IR)	Conforms
Assay (Enzymatic Activity)	Meets USP/EP/FCC requirements
Amylase Activity	Contact for details
Lipase Activity	Contact for details
Protease Activity	Contact for details
Loss on Drying	≤ 5.0 %
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>
Salmonella	Absent in 10g
E. coli	Absent in 1g

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