이수진 (대구경북첨단의료산업진흥재단)

이수진 (대구경북첨단의료산업진흥재단)

이수진 (대구경북첨단의료산업진흥재단)

이상균 (대구경북첨단의료산업진흥재단)

Extractables and leachables (E&L) assessment is essential for evaluating chemicals that may migrate from pharmaceutical containers/packaging into drug products and potentially impact product quality and patient safety. Non-volatile organic substances—such as plastic additives and antioxidant degradation products—require sensitive and selective analytical methods for reliable screening and quantitation. High performance liquid chromatography–mass spectrometry (LC–MS) provides the sensitivity and selectivity suitable for the analysis of these compounds.

In this study, we established an LC–MS analytical method using a standard mixture of representative non-volatile organic extractables associated with pharmaceutical container materials. The analytical method was also evaluated through system suitability test and linearity assessment in alignment with relevant global guidance (USP, ICH, and BPOG). The developed method met the predefined acceptance criteria, demonstrating its suitability for the analysis of representative non-volatile organic extractables in pharmaceutical container E&L studies.