Extractables Analysis of Elements in Plastic Pharmaceutical Packaging

User Benefits

- Extracted elements can be examined based on extractables and leachables (E&L) guidelines. - Elements extracted from packaging materials can be evaluated using ICPMS-2030. - The ICPMS-2030 is capable of high-sensitivity analysis of multiple elements simultaneously.

Introduction

The extractables and leachables from packaging into pharmaceuticals is a critical issue that must be addressed. This Application News uses inductively coupled plasma mass spectrometry (ICP-MS) to perform a detailed analysis of packaging extractables that targets the elements listed in the ICH Q3D guideline on elemental impurities in pharmaceuticals. ICP-MS offers a detailed breakdown as it can simultaneously analyze an extracted solution for multiple elements with high sensitivity.

June 21, 2023 GMT