Products and services

Analytical services

Characterisation of impurities

LGC provides a service in impurity evaluation and identification.

Impurities in drug substances are controlled under ICH guidelines Q3a (R2), Q3b (R2), Q3c (R3) and the EMEA Guidelines on limits of genotoxic Impurities.

These guidelines describe threshold levels for identification and qualification of impurities, the limits of which are reduced in the event that genotoxic effects are predicted.

Using a range of powerful instrumentation including NMR , high mass accuracy MS , tandem MS and ICP-MS , GC-MS and LC-MS.

LGC offers:

  • Detection and characterisation down to the levels required for genotoxic compounds
  • Assessment of impurities relating to both synthetic processes (starting materials, catalysts, side reactions) and the decomposition of active ingredients in formulated products
  • Expert synthetic input to inform identity assessment
  • Synthesis of related impurities for use as standards to verify assignments.

 

 

Pills

Our Sectors

More about our work in the pharmaceutical sector

Contact details

For more information, contact

Madhu Mittra
+44 (0)20 8943 7580
pharmaceuticals@lgcgroup.com

General:
+44 (0) 208 943 7000
info@lgc.co.uk