Taking the Mystery out of Enzyme Blends
Enzyme blends are complicated to understand, but appropriate testing can help solve the mystery that is often associated with these. There are several recommended tests for enzyme products that are identified by Good Manufacturing Practices (GMPs). These include: identity, potency, contamination and/or adulteration
It is possible to identify enzymes in a blend with mini-assays for many of the common enzymes on the market. These ID tests are not FTIR fingerprint tests, but instead show that the enzyme is still working and has not been deactivated by heat or humidity. If the enzyme in the blend does not have this wet chemistry identity test available, then the full potency assay could be completed with the ID listed as “positive per assay.”
For enzyme potency claims, most manufacturers measure enzyme activity units, “by input.” This is applicable because enzymes have interactions that are unique to each blend. When trying to follow GMP’s and FDA regulations, it’s important to test your finished products to meet all label claims. Testing of the blend is possible, but your results may differ from the “input” activities on the label because by definition, enzymes are proteins that act as catalyst for biochemical reactions. Testing the blends is the only way to fully understand these interactions. Some of the common interactions can be read here.
Since contamination can come from several sources, it is recommended to test enzyme products for common culprits such as heavy metal or microbial contamination. Heavy metal contamination could be introduced with tainted water that is used in the fermentation process or with carriers used in the drying process. Microbial contamination may come from improper handling, dirty equipment or other surfaces that have not been cleaned properly that the material touches.
Product adulteration, often the result of supplier mistakes or dishonest practices, may be difficult to identify. Research should be done to determine if there are any known adulterants for that specific material. While it’s impossible to test for every adulterant known for each ingredient, we can certainly test for specific ones that have been found to be an issue in the past. One known adulterant affecting the enzyme market is chloramphenicol. Chloramphenicol is an antibiotic that was used overseas to clean equipment or control microbial growth and consequently became a residue in finished material. With chloramphenicol being a known issue, material screening can effectively identify the presence of chloramphenicol residue. SORA Labs developed an in-house validated chloramphenicol testing method based on the FDA LIB4306. This in-house method specifically detects chloramphenicol in the enzyme matrix using the HPLC MS/MS. A proud accomplishment, SORA was recognized at the NA Residue Conference for outstanding development. More information on chloramphenicol testing can be found here.
Enzyme blends are complex, but choosing the right testing lab will go a long way in demystifying what testing is needed to ensure your products are safe and of the highest quality. SORA Labs has the enzyme expertise with this matrix and many other enzyme activity methods on their ISO 17025:2005 scope of accreditation. Let SORA Labs solve your enzyme testing mystery today!