The evaluation of extractables and leachables involves several steps. Initially, extractables are identified through rigorous testing using various solvents and conditions. Analytical techniques like chromatography and mass spectrometry are employed to characterize these compounds. Once extractables are identified, a risk assessment is conducted to determine their potential to become leachables. This involves studying the conditions under which they could migrate into the product. Leachables studies are performed under real-time storage conditions to identify the actual compounds present in the finished product.
