可萃取物和可浸出物测试

可萃取物和浸出物(E&L) studies are a critical step in establishing the safety and quality of your pharmaceutical product. 设计一个有效的E&L testing strategy capable of revealing potential extractables and leachables can pose unforeseen challenges. 当E&L测试随着行业的变化而发展, like the transition to single-use systems or changes to the 监管 landscape, it is essential to partner with experts who have experience navigating these complex processes.

在国家授权正规彩票平台, 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. 当你与我们合作时，你就是在与我们的E合作&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.