Method validation is critical to adoption of an analytical method. How does one tackle validation for direct mass spectrometry techniques? In this webcast (the third in a four-part series), we answer this question in the context of SIFT-MS, the leading automated direct mass spectrometry technique for analysis of volatile compounds.
First, we make a brief comparison of method development between SIFT-MS and conventional chromatographic techniques. Then we describe how analytical method validation is approached for SIFT-MS so that data collected can be used to support regulatory requirements. This is achieved by applying a strategic approach in accordance with ICH Q2(R1) guidelines. Finally, we will illustrate SIFT-MS method validation using two case studies: 1) common toxic volatiles in water, 2) BTEX in soil following methanolic extraction. A third case study (analysis of residual formaldehyde analysis in novel drug delivery devices) will be described in the final webinar in the series. The case studies demonstrate the efficient method development and validation (including high sample throughput) achievable using automated SIFT-MS.
View this webinar to learn more about how SIFT-MS works, how it speeds up analysis and how it can be validated successfully in accordance with regulatory guidelines.
Key learning objectives:
- Very brief introduction to SIFT-MS and its automation for those who missed Parts 1 and 2
- Method development: similarities and differences between SIFT-MS and conventional chromatographic techniques
- How to apply the ICH method validation parameters to SIFT-MS
- Two case studies of method development with SIFT-MS: soil analysis and water analysis