Intertek ASG Laboratory, Manchester, UK

Analytical Services for Registration of New Polymers

When registration is required for chemicals which are new polymers, it is necessary that number average molecular weight data is available. Frequently, performance polymers contain components of widely varying molecular weight and composition so that generation of appropriate molecular weight data which meets the regulatory guidelines is a key component of successful new product registration, especially with regards to the presence of low molecular weight oligomers. This data is critical to the registration process and can influence which registration category will apply for a new product determining, for example, whether new products can fall into the category “polymer of low concern“.

Intertek ASG has particular expertise in the characterization of the oligomers, low molecular weight polymers and associated functional groups and structures which form the scientific basis for assessing these factors.

Typical analytical technologies applied include:

Gel Permeation Chromatography (GPC) with multiple detection options
MALDI-TOF MS, Matrix Assisted Laser Desorption Ionization Time-of-flight Mass Spectrometry
NMR, Nuclear Magnetic Resonance
Titrations and wet chemical analysis for specific functional groups

In addition ASG is able to offer analysis of other components of polymers which are requirements for product registration such as solubility and extractability of the polymeric components, identity and percentage of adjuvants and additives, and the residual monomers and other reactants resulting from polymerization. ASG is also able to offer a full range of physical and chemical tests to complete the set of analytical data for registration packages. ASG has experience of working with a variety of national regulatory bodies including the UK, USA, Japan, Korea, Australia.