Method Validation of SIFT-MS Analysis of Pharmaceutical Volatiles

Validation of SIFT-MS methods for efficient, selective pharmaceutical volatiles (formaldehyde) analysis in product and packaging headspace

To mitigate risks introduced by volatile compounds in healthcare products, potential product recalls and the resulting damage to your brand, a direct and efficient means of measurement of volatile inorganic and organic compounds can be invaluable. SIFT-MS analysis can be applied to determine volatiles within the product or packaging headspace of pharmaceuticals or medical devices to deliver efficient, selective screening and product testing in real-time. Analytes include residual solvents such as those listed in ICH Guidelines and USP <467> and VOCs such as aldehydes (including formaldehyde), ketones, esters. SIFT-MS can also determine volatile inorganics such as Hydrogen sulphide, Hydrogen Cyanide or Ammonia. SIFT-MS helps to overcome challenges typically experienced using conventional chromatography approaches including specific challenges with compounds such as formaldehyde, formic acid, and ammonia. As there is no need for derivatisation, the analysis is extremely rapid.

In this seminar presentation our expert, Joe Wicks, Intertek Pharmaceutical Services, describes the steps taken to validate to ICH Q2 R1 Guidelines a SIFT-MS approach for determining formaldehyde in pharmaceutical packaging headspace. Register now to learn how extremely rapid SIFT-MS methods can be validated for volatiles analysis in pharmaceutical applications that are highly sensitive (down to sub-parts per-billion (ppb) concentrations).