Webinar – Method Validation for Quantification of Volatile Impurities by Direct Mass Spectrometry

Martin Perkins

21st November 2017

Using SIFT-MS to quantify volatile impurities such as formaldehyde.

Date:  14th December 2017
Time:  16:00 CET / 15:00 GMT / 10:00 EST

Volatile compounds are common impurities in pharmaceutical products and are often of concern due to their toxicity.  Analysis using conventional chromatographic methods can be slow and presents challenges with some substances such as formaldehyde, formic acid, and ammonia.

Selected Ion Flow Tube Mass Spectrometry (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 (Anatune Ltd) and Joseph Wicks (Intertek Pharmaceutical Services) 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.  A case study covering the quantification of formaldehyde in the headspace of a packaged pharmaceutical product illustrates this high-throughput analytical approach.

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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

Meet the Experts:

Mark Perkins, Ph.D., Senior Applications Chemist, Anatune Ltd
Mark graduated from the University of Southampton with a Ph.D. in electrochemistry.  He was a senior analyst at the Malaysian Rubber Board’s UK Research Centre, before joining Anatune in 2015 to lead SIFT-MS application development.

Joseph Wicks. M.Chem, Scientist, Intertek Pharmaceutical Services
Joseph Wicks is an analytical scientist who specialises in method development and validation for novel and advanced chromatography approaches, and physical chemical methods for use in GMP/regulatory applications.