Pharmaceuticals
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.
For further information, contact us on
Email: pharmaInfo@lgc.co.uk
LGC, The Heath Business Park, Runcorn,
Cheshire WA7 4QX, UK
Tel: +44 (0)1928 515163
Fax: +44 (0)1928 500125
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