LCGC UST
Publication|Articles|March 29, 2024

Column

  • April 2024
  • Volume 20
  • Issue 4
  • Pages: 6

Element Launches New Pharmaceutical Testing Service

Author(s)Aaron Acevedo

Element Materials Technology introduced its Rapid Response Pharmaceutical Testing Service, providing expedited testing and focusing on various requirements including active ingredients and final drug products, extractables and leachables, degradation production, and elemental impurities.

A case study done by the service using headspace gas chromatography mass spectrometry (HS-GC–MS) identified a volatile organic substance, cyclohexanone (1).

“We understand the critical importance of timely and precise testing in the pharmaceutical industry, and our new service is designed to address these needs head-on,” Iain Gibb, general manager of Element’s Manchester, UK lab, said in a press release.

Reference

(1) Ludlow, M. Characterization of Adhesive Related Leachable Deriving from Medical Infusion Bag. Element. Element Materials Technology, 2024. https://www.element.com/nucleus/2024/characterisation-of-adhesive-leachable (accessed 2024-03-21).


Related to this article

Figure 2. Split injection used to measure triplicate test of MTBE, hexane, o-xylene, and 1-methylnaphthalene comparing different solvents (methanol, methylene chloride) and column insertion distances starting with 0.5 mm, 5.0 mm, 10.0 mm, 15 mm, and 20.0 mm. Methanol had the best performance at the 5.0 mm insertion distance and methylene chloride looked slightly better at the 0.5 mm. We would still recommend not going below the 5.0 mm manufacturer recommended insertion distance.
Revisiting insertion distance for methanol and methylene chloride in GC analysis and confirming that insertion depth strongly affects response and reproducibility.