Extractables and Leachables USA, organised by Smithers Rapra, will take place on 7-9 May at the Sheraton Hotel, Silver Spring, MD.
This year’s event will feature Sarah Robinson, principal scientist, VR Analytical, where her primary responsibilities include overseeing extractable and leachable studies and elucidating the structure of unknowns utilizing 1D and 2D NMR techniques and high-resolution MS fragmentation data.
She will be presenting on the importance of choosing an appropriate anlaytical method according to the material construction.
Speaking to Extractables and Leachables, Robinson said: “A significant concentration of extractables can often go undetected or underestimated unless you know your test article and apply methods based on the materials of construction (MOC). For instance, certain wetting agents for sterile filters are not detected using these standard methods. One indication that you're missing or misinterpreting the concentration of these extractables is by comparing the measurement of the TOC in the extract to the organic carbon represented by the sum of all the detected organic extractables. If you find that, for example, only half of the TOC can be reconciled then you may need to use MOC-guided methods to discover and quantitate the rest of the extractables. There is a direct link between the toxicological assessment of a complete extractables profile and patient safety. Ensuring patient safety is why we do E/L testing."
There are many different mindsets regarding the use of TOC reconciliation. Robinson will be highlighting the main differences during her presentation at E&L USA 2014.
“Another potential reason against evaluating TOC reconciliation is that extractables studies are often part of a larger submission package and a poor TOC reconciliation can create a hurdle to overcome on a small budget or short timeline before submission. Overall though, we feel that TOC reconciliation is an efficient check that the correct analytical methods have been employed,” she said.
The full article can be found at www.eandl-conference.com/sarahrobinson-vranalytical-total-organic-carbon.aspx
Readers can benefit from 10% off their two day conference when they quote MP10AD online.