Acetonitrile adduct formation as a sensitive means for simple alcohol detection by LC-MS.

Simple alcohols formed protonated acetonitrile adducts containing up to two acetonitrile molecules when analyzed by ESI or APCI in the presence of acetonitrile in the solvent. These acetonitrile adducts underwent dissociation to form a nitrilium ion, also referred to as the substitution ion. Diols and triols behaved differently.

Evaluation of the General Solution Compatibility of Polymer Materials Used in Medical Devices such as Syringes.

Unlabelled: The general compatibility between various polymers (plastic and elastomeric materials) commonly used in medical devices (e.g., syringes) and common solution-based pharmaceutical products was examined.

Strategy for assessing the leachables impact of a material change made in a container/closure system.

Container/closure systems are extensively characterized in terms of their propensity to contribute leachable substances to the drug products they contain. Such a characterization is relevant until a change occurs in the composition or production of the container/closure system itself or the raw materials it is comprised of. When such a change occurs, it is necessary to ascertain the impact that the change would have on the validity and applicability of the previously performed leachables assessment.