Catalent Pharma Solutions is pleased to offer a new technique for the development of routine control methods for packaging extractables by accelerated solvent extraction (Respiratory Drug Delivery IX , April 25-29 2004).
Extractables methods have traditionally used low-pressure/temperature systems for the extraction of polymer and elastomer additives such as reflux, maceration and Soxhlet. Efficiency of these methods can be optimized by choosing the right solvent, or extraction times may be lengthened to ensure completeness. Both of these choices are time-intensive and may result in methods with large amounts of solvent and/or long delays from receipt of sample to final results.
Using an accelerated solvent extractor (Dionex ASE 200), temperatures above the boiling point may be used to increase the kinetics of the extraction process. A thermal analysis of the sample allows proper choice of compatible temperatures. Complete extraction can be obtained using many times less solvent and usually within 15 minutes
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Final extracts may be analyzed using any of the available techniques in the Catalent Structural Chemistry laboratory: mass spectrometry (both GC-MS and LC-MS) chromatography (GC and LC). Specialty detectors are also available for targets such as nitrosamines and polynuclear aromatic hydrocarbons (PNAs or PAHs).
As the recognized leader in the control of packaging extractables for all dosage forms, our expert staff and well-equipped laboratories are always available to help you design the right study for your product.
For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.