E & L Standards - Rubber Oligomers
References
FAQ's
References
- Dennis Jenke, Identification, analysis and safety assessment of leachables and extractables, TrAC Trends in Analytical Chemistry, Volume 101, April 2018, Pages 56-65 (https://doi.org/10.1016/j.trac.2017.10.024)
- Richard Jähnke, Contamination of Injectable Powders by Volatile Hydrocarbons from Rubber Stoppers, Acta Pharmaceutica Technologica 36(3):139-148 (https://www.researchgate.net/publication/321197618_Contamination_of_Injectable_Powders_by_Volatile_Hydrocarbons_from_Rubber_Stoppers)
Frequently Asked Questions
What are the analytical methods to identify Rubber Oligomer impurities?
GC-MS, UHPLC-CAD, and headspace MS are the analytical methods to identify Rubber Oligomer impurities.
Why is it essential to remove Rubber Oligomer impurities from drug products?
Post-marketing product recalls are avoided by removing Rubber Oligomer impurities from drug products.
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