Product Related Impurities

Intertek ASG Laboratory, Manchester, UK

Studies of Product Related Impurities and Related Substances

Intertek ASG has extensive experience in the identification and quantification of unknown organic molecules, much of this experience being applied in support to the manufacture of a wide range of fine and speciality chemicals and the identification and quantification of product related impurities. The regulatory and "on-plant" support experience of Intertek ASG ensures that this service is particularly well suited to Fine Chemical, Agrochemical and Pharmaceutical manufacturing sites working in the demanding regulatory environments of GMP/cGMP.

Specific expertise Intertek ASG can bring to bear includes:

Small scale preparative separations
Separation science (HPLC, GPC and GC)
Extensive experience of method transfer in order to pick up quickly customer developed separation methodologies
LCMS and LCMSMS capabilities for compound identification
LCNMR for confirmation of identity, isomer distribution (geometric isomers and optically active isomers) and quantification

In addition Intertek ASG is able to draw on wider expertise within the international Intertek Outsourced Laboratory network. All work can be carried out to GLP or cGMP standards as dictated by customer requirements.