Enzyme Testing in Finished Products

SORA Labs is an excellent source in the dietary supplement industry for insight on enzyme activity testing. We have been testing enzyme matrices for many years and are one of the only labs in the U.S. with enzyme assays on our ISO 17025:2005 scope of accreditation. One question we commonly receive is if it’s possible to test enzyme activities in finished products containing an enzyme blend. The answer…YES! We can test enzymes in finished products; however, like almost all analyses, it is not as straight forward as raw material testing. During our many years of experience in enzyme blend analysis, we have noticed the following phenomenon:

1) Combined Protease Effect: Occurs when different proteases are in the same blend.  In essence, they help each other out and boost all protease activities—this is known as "side activities"

2) Enzyme/Enzyme Interference: Enzymes are used to break down various substances. In enzyme blends, we often see the enzymes working against or breaking down each other. This is very common when high protease activity is blended with lactase. Lactase often falls below label claims because of the proteases acting on/or digesting the lactase.

3) Co-Ingredient Interference: Many times co-ingredients (Betaine HCl, Lemongrass, Calcium Carbonate, etc.) affect the pH of the entire mixture. Many enzyme assays are pH based and the varied pH can provide results that are not the most accurate representation of your product.

Testing raw materials can eliminate the risk of side activities or interferences, which can result in skewed results. Testing your raw materials is recommended to ensure you are putting only the highest quality ingredients in your product, and this should be followed with testing of your finished product. Most enzymes will test close to label claim; however, finished product testing will provide an accurate representation of the activities that are seen in your product, rather than activities that have been calculated by input.

Are You Testing Your Raw Ingredients?

In recent years, the FDA and other governing bodies have been tightening regulations for dietary supplement companies. Seen in the recent attacks by the NY attorney general and other agencies, they have criticized companies for mislabeling ingredients. It was unfortunate for the companies on the receiving end of these attacks because the agencies used non-traditional testing methods, which have not been proven to be effective at identifying the purity of raw ingredients. As a result, these companies faced loss of consumer trust in their products and it undoubtedly affected their bottom line. So how can you protect your company from events like this? Testing your raw ingredients is the best way to address this concern!

According to 21 CFR 111.120, companies are required to determine whether all components, packaging, and labels conform to specifications that are established in 21 CFR 111.70 (b) and (d).  These specifications are provided for each component (raw ingredient) that is used and must be established as follows:

                (b)

1.       You must establish an identity specification.

2.       You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of the dietary supplements manufactured using the components are met.

3.        You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement.

(d)

You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.

 

If you pay close attention to (b) you can see how the testing of your raw ingredients is mandatory. The minimum requirement is for ID, purity and strength to ensure your raw ingredients are what you are claiming. This documentation is also very important when you test your finished product and notice matrix interference occurring after testing has been completed. Matrix interference can cause certain analytes to be much higher or much lower than your anticipated label claim. When you have documentation of the quality of your raw ingredients, it allows for a written documentation detailing the unexpected results for reference if your product is ever under scrutiny.

Papain and Bromelain Enzyme Activity Testing

Papain and bromelain enzyme activity testing can be done here at SORA Labs.  This is one of the many enzyme assays that we preform.  We want to partner with your company on all your testing needs.

For papain and bromelain, we use the FCC PU method to determine the enzyme activity.  In some cases, bromelain is quoted in GDU activity.  GDU is not a compendial assay and has many variations of this method.  We perform the FCC PU assay, which is compendial, and then convert back to GDU.  I can send you our white paper explanation for the conversion if you let me know that you would want a copy.

FCC PU Activity Assay Description:

Hydrolysis of casein @ pH 6.0 (UV-Vis spectroscopy)

We offer many other enzyme assays from the USP or FCC Compendium. We are the only ISO lab with enzyme assays on our scope of accreditation in the US.  Please go to our website to view the complete list or email me for more testing capabilities. 

www.SORALabs.com