Smithers Enhances Extractables and Leachables Testing with New Mass Spectrometry Capabilities

Smithers Enhances Extractables and Leachables Testing with New Mass Spectrometry Capabilities

Published: 1/26/2017

(Shawbury, UK) – Smithers Materials Science and Engineering Division, a world leader in rubber, plastics and composites testing expertise, announced today the addition of its first Waters VionTM IMS QTof. Coupled with Waters AQUITY UPLC I-Class, this Ion Mobility Quadrupole Time-of-Flight Mass Spectrometer (IMS QToF) provides state-of-the-art accuracy and rapid identification of extractable and leachable compounds for the global medical, pharmaceutical, biopharmaceutical and food and beverage industries.

These new capabilities add to Smithers' industry-leading expertise in extractables and leachables studies, following industry best practices and guidance published by PQRI, IPAC-RS, USP, PDA, BPOG and BPSA, along with insights gained from FDA, EMA and ASTM. The ability of the system to generate mass data with a higher level of accuracy, along with information on fragment ions and the Collision Cross Section area (determined using the ion mobility), means that the molecular formula and structure of a compound can be quickly assigned, with the Collision Cross Section (CCS) data being used to provide an important additional dimension in the confirmation of an assigned molecular structure.

"Our new mass spectrometer further enhances our ability to provide the industry with the best techniques in identifying extractable and leachable compounds that before were unknown," said Michael Creese, Manager of Chemical Analysis. "Coupled with the knowledge and skills of our polymer and analytical experts, we will be able to provide even more in-depth and accurate testing on our clients' products and packaging materials."

Smithers' polymer and analytical experts include Dr. Patricia Wright and Dr. Selma Riasat, who joined our analytical chemistry team in 2016. Dr. Wright previously worked for multiple large pharmaceutical companies in the UK. She is a member of the British Mass Spectrometry Society (BMSS) Executive Committee and has published over 30 papers in the field of mass spectrometry, notably in mass spectral interpretation. Dr. Riasat earned her doctorate in polymer chemistry at Aston University in Birmingham, UK and conducted research at the university before accepting a position at Smithers.

Smithers has a continuous development program in place to expand its mass spectral database on extractable and leachable compounds and has committed to adding the collision cross section parameter to its library. The IQ/OQ/PQ testing of the Waters VionTM IMS QTof system has just been completed at Smithers, and the analysis of customer samples is beginning this month.

The new Waters VionTM IMS QTof system complements Smithers current structural elucidation analytical equipment, a Waters Micromass GCTTM Premier featuring both electron impact ionisation and chemical ionisation capabilities.

Smithers Materials Science and Engineering division operates laboratories in North America, Europe and China, covering a wide variety of testing and consulting services, including material chemistry and product durability testing. Smithers' global network of ISO 17025 accredited test laboratories performs a wide variety tests supporting raw material and component suppliers and end-users.

Find out more about our Extractables and Leachables testing services.

Smithers Materials Science and Engineering division was formerly know as Smithers Rapra and Smithers Pira.