Purpose-fit services to accelerate and derisk your product development
Industry interest in Extractables and Leachables testing has grown significantly in the last few years. Best practices continue to evolve and this often leads to more questions than answers. In this webinar, we explain what studies need to be performed for FDA submissions, an integral part of the regulatory approval process. We will also address the current PQRI (Product Quality Research Group) safety thresholds for injectable products.
The Extractable and Leachable (E&L) Lab workflow at Next Breath will be highlighted as a mechanism to accelerate and derisk your E&L program. For example, various solvent and temperature systems could first be utilized to characterize extracts of container closure systems. The resultant extractable information could then be used to direct the development of a targeted leachables method, or the methods developed could be more general in nature, geared towards the screening of unknowns. Using this information, risk assessments can be performed for a variety of container closure systems/packaging using guidance provided by the FDA, PQRI (including chapters 1663 and 1664), ICH, and ISO (10993).
In this webinar we will discuss equipment pros and cons for the assessment and development of methods to analyse non-volatile (LC/UV/MS), semi-volatile (direct-inject GC/MS), and volatile (headspace GC/MS) compounds. We will also share our expertise and capabilities in designing and executing E&L studies. Our experience includes mitigating common E&L challenges including the development of methods that can accommodate clients’ low analytical evaluation thresholds (AETs), the analysis of analytes even in the most complex of sample matrices, as well as the characterization of unknowns using mass spectral libraries and high resolution mass spectrometers.
