Analysis of Extractables from Pharmaceutical Packaging Materials by Solvent Extraction-GCMS and Headspace-GC-MS

User Benefits

- GC-MS can be used to analyze volatile and semi-volatile substances in pharmaceutical packaging. - High-temperature extraction can be used with a headspace sampler to analyze samples with simple pretreatment that requires no solvent. - Extracted additives can be identified easily and accurately using the Polymer Additives Library.

Introduction

Mutual interactions between the pharmaceutical and packaging are a problem with pharmaceutical packaging materials that requires particular care. Extractables are compounds generated from storage conditions that are more severe than normal, whereas leachables are compounds that can be transferred from the packaging to the pharmaceutical under normal storage conditions. They are classified as indicated in Table 1. Before pharmaceuticals can be sold, extractables and leachables must be comprehensively verified to determine packaging material risks.

November 26, 2021 GMT