Extractables and Leachables Testing
Extractables and leachables (E&L) studies are a critical step in establishing the safety and quality of your pharmaceutical product. Designing an effective E&L testing strategy capable of revealing potential extractables and leachables can pose unforeseen challenges. As E&L testing evolves in response to changes in the industry, like the transition to single-use systems or changes to the regulatory landscape, it is essential to partner with experts who have experience navigating these complex processes.
At Cambrex, we understand the nuanced nature of extractables and leachables testing and leverage our decades of experience and deep knowledge to improve our ability to predict which chemical may be present in your product. When you partner with us, you work with our E&L experts who utilize state-of-the art mass spectrometry (MS) based detection platforms that leverage comprehensive chemical libraries to conduct a thorough examination of containment-closure systems and medical devices. Our teams will work with you to design studies that may encompass several analytical techniques, including chromatographic (liquid and gas) separation techniques with MS detection such as single quadrupole, triple quadrupole (QQQ) MS/MS and quantitative time of flight (Q-TOF) in parallel with inductively coupled plasma (ICP-MS) for detection of trace metal impurities.