A Validated Method for Rapid, Direct MS Analysis of a Mutagenic Leachable: Formaldehyde

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Duration: Approximately 60 minutes

Presenters:

Mark Perkins (Anatune Ltd, UK)

Vaughan Langford (Syft Technologies, New Zealand)

Sponsor:

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Volatile compounds are common impurities in pharmaceutical products and are often of concern due to their toxicity (e.g., as mutagens or genotoxins).

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 approach 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.

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.

By viewing this presentation you will learn...

• The fundamentals of the selected ion flow tube mass spectrometry (SIFT-MS) technique, including its ability to selectively and comprehensively analyse samples in one, simple procedure.
• An approach to validation of direct SIFT-MS analysis in accordance with ICH Q2 (R1) Guidelines so that the data generated are GMP compliant and can be used in regulatory submissions.
• The application of the validation approach using a case study: formaldehyde quantification in the headspace of a packaged pharmaceutical product.

SIFT-MS is a cutting-edge direct MS technique for real-time, quantification of trace volatiles to sub-part-per-billion (ppb) levels. Join Mark Perkins and Vaughan Langford to learn about SIFT-MS and how this direct analysis technique can be successfully validated in accordance with ICH Q2(R1) Guidelines to achieve GMP compliant data suitable for regulatory submissions.

To view this on-demand webinar complete the form to the right of this page.