Fatty Acid Extractables/Leachables Profiles as an Indicator of Technical Grade Stearate Acid Additive Origin - Seguridad Mania.com - España y América Latina

Medium-chain fatty acids are used extensively as additives to plastics and elastomers. Plastics and elastomers are in turn used in the fabrication of components which then are used in the fabrication of drug product container closure-delivery systems and medical devices. As a result, these medium-chain fatty acids routinely appear in extractables profiles from these components as well as in leachables profiles of drug products. The most commonly used medium-chain fatty acid additive is “Technical Grade Stearic Acid” either as the free base or salt (e.g., Mg, Ca, Zn). Technical Grade Stearic Acid contains a mixture of fatty acids, with Palmitic (C16) and Stearic (C18) acids being the most abundant. These fatty acid mixtures are of biological origin, either plant or animal derived (bovine). It is well established in the scientific literature that the ratios of C16/C18 in fatty acid mixtures vary with origin. This presentation focuses on the use of extractables and leachables profiles to indicate the origins of fatty acid additives in packaging and medical device components. Data will be presented from both GC/MS and LC/MS analyses of various extractables/leachables profiles and compared with the chromatographic profiles of fatty acid mixtures of known origin. It will be shown that plant and animal derived C16/C18 ratios can be distinguished by either analytical technique, alerting the analytical chemist to the possibility of a bovine sourced additive with the potential of carrying Bovine Spongiform Encephalopathy (BSE).