Stability Testing in Vitamins and Supplements
Stability testing ensures your products efficacy and tests for any contamination that has occurred over its shelf life. It is one of the most critical,
yet underutilized tests in the supplement and nutraceutical industries.
Effective stability testing will analyze a product periodically, ensuring active ingredients are within the acceptable range and free of any contamination.
Finished products pulled off the shelf are failing potency, heavy metals, and microbial testing at an alarming rate. We find that in many of these cases, stability testing was never conducted.
Why is it so important?
In most cases, products are not being sold/consumed as soon as they are packaged from the manufacturer. Your product is sitting in its finished packaging in a store or in a warehouse until a consumer makes a purchase.
The testing done on raw materials alone or the finished bulk product is not sufficient nor representative of what is being sold and consumed 6, 12, 18, and 24 months later. .
There are quite a few factors that can negatively affect your product during these time periods, some of the most common being:
Environmental factors (i.e. UV exposure, temperature, oxygen, moisture)
Microbial Growth
Oxidization
Metallic ions
Heavy Metal Contamination
pH Levels
The same product that passed contamination testing after 12 months may fail after 18-24 months.
What is Causing Contamination?
The Packaging
The most important and often overlooked issue is the packaging itself. It is very common for heavy metal and microbial contamination to occur as a result of the bottle or package being contaminated.
Certain packaging materials can react very poorly to differing levels of light, heat, and humidity. Additionally, even if stability testing has occurred, it was not conducted in the packaging that was intended to go to market.
2. Active Ingredient Interactions
Products, especially those with multiple active ingredients, are at a high risk to interact with each other in a myriad of ways. This can cause the product to rapidly lose efficacy. Certain ingredients may also react very negatively to differing levels of light, heat, humidity, and pH
3. Difficult Product Types
Gummies, liquid supplements, and water soluble vitamins can be extremely difficult to maintain stability with a high level of expertise often involved. Stability testing is especially critical to ensuring the safety of these products
Why Brands are Opting Out
The pharmaceutical industry requires stability testing, unfortunately this is not the case for supplements and nutraceuticals. Stability testing is not required by the FDA or any regulatory US agency. As a result, many manufacturers and brands forgo this.
What Can Manufacturers and Brands Do?
We understand that for many companies starting up or launching new products, it is unrealistic to undertake stability testing before launching a new supplement or vitamin product. We encourage all of our clients to test their packaging for any heavy metal contamination that could tarnish the end product. Ethos Analytics can test your packaging, so that you may avoid pricey and time wasting packaging and formulation changes months after launch.
This industry is growing, but so is the skepticism along with it.
“According to the survey, 95% of consumers have concerns about the quality and safety of dietary supplements, personal care products and OTC drugs.”
