Evaluation of extractables in processed and unprocessed polymer materials used for pharmaceutical applications.

Polymeric materials are often used in pharmaceutical packaging, delivery systems, and manufacturing components. There is continued concern that chemical entities from polymeric components may leach into various dosage forms, particularly those that are comprised of liquids such as parenterals, injectables, ophthalmics, and inhalation products. In some cases, polymeric components are subjected to routine extractables testing as a control measure.

Use of thermal desorption GC-MS to characterize packaging materials for potential extractables.

This article presents case studies involving the use of thermal desorption gas chromatography-mass spectrometry to compositionally characterize pharmaceutical packaging materials for potential extractables. Knowledge of potential extractables and leachables early in the product development program allows the project team to make informed decisions, potentially minimizing redevelopment efforts and reducing cost. Case studies include selection of a label for use on a polyethylene bottle, selection of a drug contact surface of a blister packaging system, and selection of a stopper.