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Techniques & Tools Pharma & Biopharma, Mass Spectrometry

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

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

Join us for this educational 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.

Learning Objectives of Webinar

  • 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.
  • 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.

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