There is nothing simple about the process of developing methods for an analytical lab. Using compendial methods from reliable sources like USP, AOAC, FDA, BP, JP, etc. for third-party verification and quality control testing is always your best option. In some cases, however, the ingredient that needs verification does not have a compendial method available. In fact, manufacturers may produce an ingredient and develop a test method specifically for that product. In these situations, a contract lab like SORA Labs, will need to work directly with the supplier to transfer the method to the lab.
Method transfer and development takes time to get up and running, so planning ahead of your product launch is critical. After receiving the method from the ingredient supplier, the lab will attempt the assay. There is usually further discussion and proficiency testing after this first attempt to get accurate and repeatable results. Often, the method that is transferred will only be applicable to the raw material, and it can be challenging to adapt the method to a finished product matrix.
Ingredients like probiotics with CFU/g counts, white kidney bean extract with alpha-amylase inhibition testing and even special gluten-digesting enzymes are examples of ingredients that can be difficult to test once included in a blended matrix. While this testing can be tricky, it’s not impossible for a competent lab. Since test methods for these types of ingredients are designed for the raw materials and simple finished products, there may be additional method development when assaying the ingredients in a complex blend. In some rare instances, the resources and time it takes for method development may be cost-prohibitive to develop the product, so testing during research and development can prevent impossible challenges down the road. A rule of thumb—the simpler the blend, the more straight-forward the testing will be. Understanding the possible challenges up-front will give you a better understanding of the formulation process and what it might take to create your product.
When enzymes and probiotics are in your formulation, SORA Labs wants to be your specialty testing lab of choice. Call us today for a quote!