Understanding Enzyme Testing: Tips from the Experts

When contemplating test methods for enzymes, it’s important to understand that enzyme activity assays have many compendial and non-compendial units associated with them. While the enzyme industry has gotten closer to standardizing supplement raw materials to the activity units listed in the Food Chemicals Codex (FCC) and the United States Pharmacopeia Dietary Supplements Compendia (USP-DSC), they still have some distance to cover.

When purchasing a raw material or blend of enzymes, it’s a time-saving measure as a manufacturer or marketer, to confirm that the specifications are sold in compendial units, whenever possible. This limits the need to find or use a conversion when trying to determine if the material passes your quality review process. If you are purchasing an enzyme that is sold with only an industry method, then we can advise you if we can run the specific method you need for the material. Understanding the test method before-hand will save you time, hassles, and allow for a smoother finished product release process later down the line.

Here is a list of common compendial units from the FCC or USP.

  • Common fungal & plant activity units:
    • Proteases: HUT/g, PU/mg, PC/g, SAP/g
    • Lipase: FIP/g or LU/g
    • A-Amylase: DU/g
    • Cellulase: CU/g
    • Lactase: ALU/g
  • Common animal enzymes-all USP compendial units
    • Pancreatin: Shows three activities in pancreatin Amylase, pancreatin Lipase and pancreatin Protease all listed in USP/mg.
    • Pepsin: FCC or USP/mg is sold in ratios like 1:10,000, etc.
    • Trypsin: USP/mg
    • Chymotrypsin: USP/mg
  • Industry methods or non-compendial activities:
    • Nattokinase FU/g: –Knowing the country of origin is key to running the correct method. The most common method is from Japan, but there are also Korean and Chinese methods.
    • Superoxide Dismutase (SOD):
      • McCord Fridovich method: </> 8000 MCF/g (ONLY raw materials)
      • Dojindo Kit: < 1 unit/g and a common material specification is 14,000 IU.
    • Serratiopeptidase: This industry method is similar to British Pharmacopeia method.
    • DPPIV Units:-Protease activity
    • AAIU Units:– Alpha-amylase Inhibition activity
    • PPI Units: Tolerase G protease activity

For more information and a robust list of enzyme activity assays, check out our enzyme testing flyer .

A common misunderstanding when customers are ordering enzyme activity testing is for them to request activity in “USP units”. Generally, “USP units” are associated with animal-derived enzymes. When testing fungal or plant enzymes, the actual activity unit and not the general nomenclature should be requested.

Supplying the raw material certificate of analysis (cofa) and quantity of the raw included in the blend will allow us to easily determine what units and theoretical activity are necessary for the product testing. Since having the correct assay run on the material is the key to obtaining results that are accurate for the product, partnering with an experienced specialty testing lab will go a long way to ensure the quality of your product. Contact us for a quote today!
Here are some helpful links to calculators on our website:

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