Are you in the business of selling supplements? Do you know what stability testing is and why it’s critical for your product’s success?
Picture this: your supplement has been on the shelf for a few months, and you’re starting to see a drastic dip in sales. You begin to panic and wonder why your once-popular product is now collecting dust. The answer may lie in stability testing.
This crucial process allows you to determine your supplement’s shelf life and expiration date, preventing surprises down the line (and ensuring the quality of your products).
In this blog post, we’ll take a deep dive into stability testing and explain why it’s a vital aspect of any supplement’s regulatory approval process.
What Is Stability Testing?
Stability testing is a crucial process for any pharmaceutical or supplement product – one that ensures its safety, efficacy, and chemical composition over time. Think of it as a way to determine the shelf-life and expiration date of your product.
As any product sits unused, it will eventually undergo changes – physical, chemical, or both – that can impact its performance or its safety. Stability testing helps identify these important changes and makes sure that everybody has the information they need to verify what they need to verify – namely, the safe labeling, handling, and storing conditions of the products. This is important for regulatory bodies and governing agencies, but also for anybody involved in production and marketing in your company, too.
There are all kinds of factors that can impact the stability of your product, including light, temperature, humidity, and more. The ultimate purpose of stability testing is to simulate the real-life conditions (such as these) that your product may experience during storage and transportation.
This helps you understand how your product may change over time and allows you to make any necessary adjustments – that way, you can make sure it remains effective and safe. Ultimately, stability testing serves the purpose of making sure products are safe, but also to help you market your products safely and effectively as well.
How Stability Testing Is Done
Stability testing is ideally conducted throughout the entire product development process, from initial formulation to final packaging. The Food & Drug Association (FDA) recommends that it happen initially when the product is developed, then every three months for the first year and every six months moving forward.
It typically involves subjecting samples of your product to various physical and chemical stressors mentioned earlier, such as extreme temperatures, humidity, and light exposure. These stressors are applied for a set period, and then the product is analyzed to see if there have been any changes in its potency, quality, or safety.
Several different methods can be used to assess the stability of supplements and other pharmaceuticals, including high-performance liquid chromatography and gas chromatography. Liquid chromatography-mass spectrometry is another method, as is HPLC-diode detection, which measures wavelength as a function of real-time.
Regardless of the method used, stability testing is an important part of the regulatory approval process for any supplement or pharmaceutical product.
How Long Does Stability Testing Take?
Depending on the product, stability testing can take anywhere from a few months to several years. The duration of stability testing is determined by a variety of factors including the type of product being tested, its intended use, and any regulatory requirements.
It’s important to note that stability testing isn’t a one-time thing. It’s an ongoing process that must be repeated periodically to ensure that a product remains safe and effective throughout its entire shelf life.
This means that even after a product has been approved, it must continue to undergo stability testing at regular intervals.
Importance In the Supplement Industry
Here are a few more reasons why stability testing is an integral part of the supplement industry.
Shelf Life
Shelf Life testing is used to determine the duration a product can retain its quality as well as evaluate the characteristics of the supplement for storing over a long period of time. These tests are done to ensure that products don’t degrade or see a decrease in quality. Creating Stability Tests allows manufacturers to create a “best by”, “use before” or expiration date on your products.
Many manufacturers gather much of their information for data claims from the National Sanitation Foundation more commonly known as NSF International, who have created a Stability Testing guideline. Following this guideline helps manufacturers to understand how things such as packaging, labeling, distribution and even the manufacturing process itself affect the stability of a product.
Preventing Spoilage
Another key benefit of stability testing in the manufacturing industry is the prevention of spoilage. Spoilage can occur when supplements are exposed to conditions that promote the growth of bacteria and other microorganisms, causing them to become unsafe.
Stability testing can help manufacturers identify the key factors that contribute to spoilage – such as temperature and humidity – so that packaging and storage protocols can be created to aid in preventing spoilage from occurring. For example, by testing products under these different conditions, manufacturers can determine the best packaging materials to use to prevent spoilage and maintain the supplement’s quality and stability.
It’s also important to note that stability testing can help manufacturers identify potential sources of contamination in the production process itself. When they’re able to monitor bacteria levels in products at different intervals, manufacturers can identify when and where contamination occurred, allowing them to take steps to prevent similar issues in the future and streamline (and improve) their production processes.
Compliance With Regulations
Stability testing also helps ensure compliance with regulations. In the supplement manufacturing industry, all products must be tested and shown to be stable over a certain period of time to receive regulatory approval.
To guarantee the safety and quality of these products, stability testing is required to determine the optimal processing conditions – such as temperature and time – that will effectively destroy bacteria without compromising the quality of the supplement as set out by the NSF and other guidelines created by the FDA.
Gain A Competitive Edge
In addition to ensuring compliance with regulations, stability testing can also help manufacturers improve their products and gain a competitive edge in the marketplace.
By understanding how their products behave under different conditions, manufacturers can make more informed decisions about how to package, store, and market their products – ultimately leading to better outcomes for both consumers and the industry as a whole, but also for their businesses.
Work With SMP Nutra For Your Supplement Needs
At SMP Nutra, we understand the importance of stability testing, which is why we offer a comprehensive range of testing services, including third-party GMP, gluten-free, identity, potency, microbials, heavy metals, and allergen testing.
Our experienced team has over 50 years of combined experience in manufacturing dietary supplements, and we use only the most modern equipment and high-quality raw materials to produce top-notch nutraceutical products.
If you’re looking for a reliable and efficient supplement manufacturer, look no further than SMP Nutra. With our turnkey service, fast turnaround times, and minimum order quantities starting at just 1,000 bottles, we’re the perfect partner for all your supplement manufacturing needs. Contact us today to learn more about how we can help bring your supplement ideas to life!