Thermal Desorption – GCMS Method for Screening Analysis of Extractables in Drug Packaging Materials

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. Analysis methods are needed for the detection and quantitation of extractables and leachables in pharmaceutical packaging and products. Solvent extraction steps for extractables are usually timeconsuming, including heating, liquid-liquid extraction, concentration and so forth. Here, we describe a simpler screening analysis method for volatile and semivolatile extractables in the packaging of ophthalmic solution by thermal desorption (TD) – GCMS. The results were compared with leachables result of ophthalmic solution measured by GCMS with liquid injection.

Content Type:
Document Number:
ASMS 2020 - ThP 172
Product Type:
Gas Chromatography Mass Spectrometry
Pharma & Biopharma, GCMS-QP2020 NX Single Quadrupole GC-MS, TD-30 Series Thermal Desorption Unit
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