Pre-release laboratory testing (oral-use products)

Before release, every oral-use batch undergoes extensive enzymatic-activity testing:

• Identity & activity: trypsin/chymotrypsin verified with enzyme-specific activity assays.
• Activity, not milligrams: activity is quantified per dose and per gram.
• Robustness: stress checks (time/temperature/humidity) and trend analysis against acceptance criteria.

Result

A batch leaves the lab only when its measured activity meets specification.

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For meaningful comparison, enzymatic activity should be measured and stated in FIP units. FIP (Fédération Internationale Pharmaceutique) units, adopted by the European Pharmacopoeia (Ph. Eur.), quantify protease activity on a standardized casein substrate under defined pH and temperature. That makes results comparable across batches and manufacturers.

Other unit systems (e.g., GDU, USP, PU) are not harmonized and can vary by method and lab, which complicates international comparison. Using FIP units is key to clarity and transparency—especially for trypsin and chymotrypsin.

The importance of enzymatic activity and FIP units

For enzymes, the decisive factor is not their mass (mg) but their enzymatic activity—i.e., the functional ability of the enzyme to cleave a substrate under defined conditions. The key parameters are therefore specific activity (activity per mg of enzyme) and the resulting total activity per dose. Two products containing the same mass of enzyme in mg can have completely different effects if their enzymatic activity differs.

In the European Union, when declaring proteolytic enzymes—especially trypsin and chymotrypsin—the use of FIP units is expected. This internationally harmonized pharmaceutical unit, established by the European Pharmacopoeia (Ph. Eur.), measures an enzyme’s ability to cleave a standardized casein substrate at precisely defined pH and temperature. FIP units are therefore comparable across batches, manufacturers, and even different enzymes, enabling transparent comparison of product potency.

By contrast, some other units (e.g., GDU, USP, PU) are not harmonized and may differ in methodology even between manufacturers, complicating international comparisons. For this reason, European legislation and food-supplement notification systems (e.g., in Germany, Italy, Austria) prefer or explicitly require the declaration of enzymatic activity in FIP units, especially for animal-derived enzymes.

Trypsin and chymotrypsin, as highly specific and technologically demanding animal enzymes, are therefore significantly more expensive than common plant proteolytic enzymes (bromelain, papain) or bacterial enzymes (e.g., serratiopeptidase). Products that contain high doses of these enzymes with verified high enzymatic activity in FIP units naturally fall into a higher price and quality category. In contrast, preparations based solely on bromelain or papain, or those containing low-activity animal enzymes, may be more affordable but might not offer comparable performance.