Method Validation for Quantification of Volatile Impurities by Direct Mass Spectrometry

Using SIFT-MS to quantify volatile impurities such as formaldehyde

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 and Joseph Wicks 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.

Thursday, December 14, 2017 10:00 AM - 11:00 AM EST