Thermal Desorption - GC/MS Method for Screening Analysis of Extractables in Drug Packaging Materials

Introduction

Both extractables and leachables (E&L) from pharmaceutical packaging materials and products are of utmost concerns by authorities, since they may affect the efficacy, quality and safety [1]. Many regulatory guidance documents have been established regarding E&L approach and assessment. However, details on how to perform E&L evaluation in various packaging materials and products is still under discussion and development. Extractables are defined as the compounds that can be extracted from a drug packaging under certain conditions, e.g. in solvent and/or with heating. Meanwhile, leachables are compounds that migrate from the drug packaging into the drug under normal storage condition. Theoretically, leachables emerge from extractables, although not all leachables are extractables in practice (Figure 1) [2]. Analysis methods are needed for the detection and quantitation of extractables and leachables in pharmaceutical packaging and products. Here, we describe a screening analysis method for extractables in the packaging of ophthalmic solution by thermal desorption(TD)–GC-MS. The result is compared with leachables result of ophthalmic solution measured by GC-MS with liquid injection.

June 19, 2020 GMT