Detection of leachables in vaccine from plastic packaging

04 July 2016

A method to identify main leachables-polymer additives in medical products was developed by ultraperformance liquid chromatography-quadrupole time-of-flight-mass spectrometry and a self-built library. The library contains 174 additives and the information on their names, formulas, structures, retention times, fragments, classifications, origin, and corresponding MSE and MSMS spectra.
The reliability of the construction process of the library was guaranteed by the system stability and suitability test. Identification parameters of library application, such as mass error, retention times, fragments, and isotope pattern, were evaluated (Analytical Chemistry, 3 June 2016).
Click here for an abstract of the article.
Click here for more information about the module Pharmaceutical packaging regulations of the NVC E-Course Pharmaceutical Packaging.

If you have any questions about this subject, please contact us: info@nvc.nl, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.