Extractables and Leachables Team expands capabilities with the addition of Time of Flight Mass Spectrometers
Evaluation of packaging and/or drug delivery materials and manufacturing components for extractable and leachable (E&L) compounds is an expectation of the regulators. Eurofins Lancaster Laboratories has been performing E&L work for over eight years and has recently improved its ability to determine and evaluate nonvolatile extractable profiles through the purchase of new Time of Flight (TOF) Mass Spectrometers. This system brings a distinct advantage in the molecular weight determination and compound identification capabilities to Eurofins Lancaster Laboratories.
The new liquid chromatography/mass spectrometry (LC/MS TOF) system is a state-of-the-art system that is designed for both high throughput and accurate mass measurements. The system is equipped with UHPLC, providing decreased instrument run times without the loss of resolution. The system is equipped with a multi-mode source that allows for both chemical ionization and electro-spray ionization in a single run. It also features the molecular feature extractor, which allows for data mining in complex extractable chromatograms.
The new TOFs allow accurate mass measurements to be made to within 2 ppm, which greatly improves the ability to positively identify unknowns. The resultant data can be compared to an extensive database of common extractable compounds generated by Eurofins Lancaster Laboratories, allowing for identification based on accurate mass. If the database does not provide a positive match, the system’s formula search software can provide potential molecular formulas based on the accurate mass of the extractable compound.
Typical single quadrupole or ion trap mass spectrometers assign a less accurate mass for the extractable compound in question when compared to TOF. When performing a molecular formula search targeting only carbon, hydrogen, nitrogen and oxygen, a considerably larger list of possible matches are generated utilizing the less accurate mass. Using TOF and the same search parameters allows for a significant reduction in the number of molecular formulas that match the accurate mass. This system allows the Extractables and Leachables Team to provide more relevant information on the extractable compounds observed, allowing for a more complete evaluation of the data from a toxicological perspective.
For more information on Eurofins Lancaster Laboratories capabilities in the area of extractables and leachables, please contact your business development representative or visitwww.lancasterlabspharm.com.