이상균 (대구경북첨단의료산업진흥재단)

이수진 (대구경북첨단의료산업진흥재단)

이상균 (대구경북첨단의료산업진흥재단)

이수진 (대구경북첨단의료산업진흥재단)

Pharmaceutical containers/packaging materials can release extractables and leachables (E&L), which may affect drug product quality and patient safety. Extractables are organic or inorganic chemical substances released from packaging materials under exaggerated extraction conditions, whereas leachables are compounds that migrate into drug products under actual conditions of use.

Elemental (inorganic) extractables are of particular concern because trace metal impurities may contribute to patient risk depending on route of administration and exposure level, including potential systemic toxicity and, for certain elements, cumulative effects upon repeated dosing. Therefore, sensitive multi-elements screening is required to support a robust risk assessment for pharmaceutical container materials.

In this study, elemental extractables from pharmaceutical container materials were analyzed using inductively coupled plasma mass spectrometry (ICP–MS). Testing criteria were established based on USP and ICH guidelines and BPOG guidance. Thirty elements (Li, Mg, Al, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Se, Mo, Ru, Rh, Pd, Ag, Cd, Sn, Sb, Ba, Os, Ir, Pt, Au, Hg, Tl, Pb, Bi) were included, and method performance was evaluated via system suitability testing, linearity, limit of detection (LOD), and limit of quantification (LOQ). The validated approach is intended to support the characterization of elemental extractables potentially originating from pharmaceutical containers and to strengthen patient focused E&L assessments.