Practical Challenges of Stability Testing of Nutraceutical Formulations
Nutraceuticals are a growing segment of the global consumer market. Until recently, it can be argued that the manufacturing and quality control of these products to include dietary supplements, botanicals, fish and animal based supplements, etc., has been largely unregulated in the United States. In addition to requirements from the compendia (USP, NF) which may not apply if the product is not labeled USP, the USFDA has recently (June, 2007) enacted regulations, which are not very clear on the requirements for expiration dating and supporting data and testing methods’ validity. With this confusing regulatory requirements backdrop, the challenges for stability testing of nutraceutical formulations only get tougher, when one considers the complexity of multiple active ingredients, formulation and natural matrix effects and isolation of representative marker compounds. This article describes these challenges and attempts to provide a navigation compass to the pharmaceutical/nutraceutical scientist through this complex maze.