The safety of pharmaceuticals, cosmetics, and foodstuffs may be compromised by chemical compounds in the various types of packaging and food contact materials (FCMs) that are in direct contact with the consumer product.
Due to continuously increasing global regulations, the characterization of extractables and leachables from packaging and FCMs has become more critical than ever for the manufacturers that supply the pharmaceutical, food, and cosmetics industries.
These chemical compounds are typically categorized as:
- Extractables – compounds which are extracted from packaging or device components under controlled extraction conditions.
- Leachables – compounds which migrate from the packaging into the product during its normal shelf life.
- Non-intentionally added substances (NIAS) – degradation products from FCMs, impurities of starting materials, and contaminants from recycling processes.
For characterizing extractables in packaging, the initial step includes targeted screening, i.e., testing the extracts for known compounds. This is a well-established process and can be performed in various ways by using analytical techniques ranging from GC-FID-MS to LC-UV-MS.
However, the final packaging may have impurities present from starting materials and additional degradants such as those formed during the molding process. The structural elucidation of unknowns is typically a very complex and time-consuming process that requires the analyst to have a high level of expertise.
Waters UNIFI Scientific Information System provides a simple workflow for use with high-resolution mass spectrometry analysis, including ion mobility MS, that can streamline the structural elucidation process. UNIFI software features include scientific library creation, multivariate statistical analysis, elucidation, and reporting. By integrating the analytical platform with application-specific informatics, we’re enabling analysts to evaluate complex data in a more efficient way by simplifying data review, which can facilitate the decision-making process.