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Pancreatin

Pancreatin suppliers and sourcing guide

Pancreatin is a mixture of enzymes extracted from hog or ox pancreas, containing protease (mainly trypsin and chymotrypsin), amylase and lipase. Pancreas glands are minced, activated, extracted and dried, often with defatting, to a white to tan powder. Buyers purchase it by strength, stated in USP units of each enzyme, for supplements, protein hydrolysis and starch processing.

Category
Enzymes
Also known as
Pancreatic extract · Pancreatic enzymes · Porcine pancreatin · CAS 8049-47-6
Facts checked
November 2026

Forms and grades of pancreatin

Suppliers sell different products under the same name. Specify the one you need.

  • USP strength multiples

    Powders labeled as multiples of the USP minimum strength, such as 4X or 8X, with stated amylase, lipase and protease activity.

  • Porcine vs. bovine

    Most pancreatin is porcine; bovine grades exist and matter for buyers with religious or dietary limits.

  • Enteric-coated granules

    Coated grades so the enzymes pass stomach acid, sold at lower activity per gram.

  • Diluted or standardized blends

    Pancreatin cut with lactose or other carriers to a set activity; check the carrier for allergen status.

What to check on the COA

Compare each result with your own specification when the lot arrives.

Enzyme activities
Amylase, lipase and protease activity in USP units per mg by the USP pancreatin assays; all three should be on the COA.
Fat content
Residual fat, since non-defatted grades can turn rancid and clump.
Animal origin documentation
Species and country of origin of the glands or tissue, with veterinary or health certificates and, for porcine material, a statement for halal or kosher buyers who need it.
Loss on drying
Moisture for powders by loss on drying; enzyme activity holds up better in dry product, so moisture above spec is a warning sign for activity loss in storage.
Heavy metals
Lead (and often arsenic, cadmium and mercury) by ICP-MS, reported against FCC enzyme-preparation limits or the supplier's specification.
Microbiology
Total aerobic count, yeast and mold, and absence of Salmonella and E. coli, important for an animal-tissue ingredient.

Storage, lots and expiry

Storage and shelf life

Keep pancreatin sealed in a cool, dry place, and refrigerate if the supplier specifies; lipase activity is the least stable and drops first in warm or humid storage. Shelf life is set by the supplier's specification as minimum activities to a date, and older stock is retested for all three activities before use. Supplier safety data sheets call for dust control and respiratory protection, since the powder can irritate skin and airways.

Lots and expiry dates

The ratio of lipase, amylase and protease differs between lots, so record all three activities for each lot and set the dose by the limiting one. Keep animal species and origin records with each lot and rotate stock first-expired, first-out.

Regulatory status

Facts from regulators and standards bodies, each linked to its source.

This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.

Pancreatin suppliers

Manufacturers and distributors whose own websites say they sell it.

We are checking pancreatin suppliers now

Every listing is checked against the supplier’s own website before it goes live, so this list fills in over the coming weeks. The specs and COA checklist above are ready today.

Sell pancreatin? Request a listing

Frequently asked questions

What forms of pancreatin can brands buy?

Common forms include uSP strength multiples, porcine vs. bovine, enteric-coated granules and diluted or standardized blends. Ask each supplier for the specification sheet of the exact grade they quote.

What should the COA for pancreatin include?

Expect enzyme activities, fat content, animal origin documentation, loss on drying, heavy metals and microbiology, each with its method, specification and result for that lot.

How should pancreatin be stored?

Keep pancreatin sealed in a cool, dry place, and refrigerate if the supplier specifies; lipase activity is the least stable and drops first in warm or humid storage. Shelf life is set by the supplier's specification as minimum activities to a date, and older stock is retested for all three activities before use. Supplier safety data sheets call for dust control and respiratory protection, since the powder can irritate skin and airways.

What is the regulatory status of pancreatin?

21 CFR 184.1583 describes pancreatin as an enzyme preparation obtained from porcine or bovine pancreatic tissue and affirms it as GRAS as a direct food ingredient used to hydrolyze proteins or polypeptides. Health Canada's List of Permitted Food Enzymes includes pancreatin (item P.1) from the pancreas of the hog or ox. Health Canada's Digestive Enzymes natural health product monograph lists pancreatic enzymes from Bos taurus and Sus scrofa pancreas, under names including pancreatin.

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