In an opinion article published on December 7, 2018, by regulatory news provider Chemical Watch, Yawei Zhang from the consultancy Knoell Germany reviewed some of the techniques used to characterize polymers as requested by “varying regulations across the world.” In particular, she discussed the definition of a polymer given by the Organization for Economic Cooperation and Development (OECD) in 1993, challenges in polymer nomenclature, country-specific differences in polymer regulation, and specifics of polymer analytics.
Characterization of polymers is complicated, because “the ‘substance’ to be characterized is a mixture of molecules that vary widely in MW [(molecular weight)], composition or both.” Zhang provided an overview of methods used to analyze these two characteristics, with most attention given to MW-focused methods. She concluded by saying that, “while physico-chemical characterization of polymers can be challenging, it is essential to understand their structure and composition, so that the information provided in any regulatory submission represents the actual substance that is intended to be distributed in commerce.”
Yawei Zhang (December 7, 2018). “Characterization of industrial polymers for regulatory submission.” Chemical Watch