As your partner in quality, we have the fifty-thousand foot view privilege. SORA Labs is known for problem solving and working closely with customers to analyze complex formulations, thousands of test come through our doors. Let’s talk about the most complex ingredient/nutrient formulations that bring analytical challenges with them.
*Enzymes and probiotics are sensitive to heat and humidity. They also come with special handling instructions, and as the weather gets warmer, it’s a good idea to ship samples overnight or in a cooler with ice packs. The goal for testing is to have results that are representative of the material being stored at your facility. If these sensitive materials get too hot they could degrade in shipping, then the test results would not accurately represent your material.
*If it’s not recommended, leave the spec off…it’s OKAY, honestly! When setting required specifications for probiotic products, review monographs from the United States Pharmacopeia (USP)/Food Chemical Codex (FCC) or other compendia for guidance. You will notice, the probiotic monographs don’t recommend total plate count (TPC)/aerobic plate count (APC) specifications. Instead of listing APC/TPC, labeling recommendations established by International Probiotic Association (IAP) and Council for Responsible Nutrition (CRN) in a development of scientifically-based “Best Practices Guidelines for Probiotics” recommends labeling guideline specifications to colony forming units (CFU)/gram, which have been included in the FCC.
*Both probiotics and enzymes can have interferences from co-ingredients in the blend. Another popular sample submission is the food/gummy matrix, which can also create testing challenges. We can help! See our “Challenge Accepted” blog for insights on common interferences.
*Avoiding FDA Warning Letters and 483’s for lack of finished product testing is the brand owner’s/manufacturer’s responsibility. Supplement products are complex and testing interferences in the finished product are common. These interferences may make it impossible to meet the label claim on the bottle for every ingredient, but testing can prove these interferences. Documentation is the key to a successful FDA inspection.
Just remember, the goal is to procure testing from experienced lab partners that can provide accurate CofA data. SORA Labs wants to be that partner, providing a seamless extension to your quality control department!