An Approach to Pharma Method Validation for Direct Mass Spectrometry
29 Jan 2019
Volatile compounds are common impurities in pharmaceutical products and are often of concern due to their toxicity. They can also represent a health and comfort hazard, both indoors and out. However, analysis using conventional chromatographic methods is slow, due to both sample preparation and chromatography.
SIFT-MS is a new analytical tool for real-time, selective, and economical trace gas and headspace quantification of volatile compounds, including chromatographically challenging ones, such as formaldehyde, formic acid, and ammonia. But how do you approach analytical method validation for SIFT-MS so that the data can be used to support regulatory requirements? By applying a strategic method in accordance with ICH Q2(R1) Guidelines to direct SIFT-MS methods – and utilizing formaldehyde analysis as a case study – successful validation is readily achieved.
Join us for 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 ICH Q2(R1) guidelines suitable for pharmaceutical applications, such as regulatory submissions where GMP compliance is essential.
Key learning objectives:
- Learn the fundamentals of the selected ion flow tube mass spectrometry (SIFT-MS) technique, including its ability to selectively and comprehensively analyze samples in one, simple procedure
- Discover how direct SIFT-MS analytical methods can be validated in accordance with ICH Q2 R1 Guidelines so that the data generated is GMP compliant and can be used in regulatory submissions
- Understand the application of this validation approach through a case study covering formaldehyde quantification in the headspace of a packaged pharmaceutical product
Who Should Attend?
- Analytical Chemists
- QA/QC Managers and Scientists
- Method developers and validators
- Researchers / R&D Managers
- Laboratory Managers / Directors / Supervisors
- Analytical Outsourcing Managers