Intertek ASG Laboratory, Manchester, UK

Early Phase Drug Product Stability Studies

Early identification of potential problems with the stability of new APIs and their formulation into new drug products is an important aid to getting drug development "right first time". It is also necessary to undertake stability studies at an early stage in drug development to demonstrate stability over the duration of proposed early phase clinical trials. At this early stage, stability trials can be technically complex, requiring advanced hyphenated instrumentation (e.g. LC-MS, LC-MS/MS, LC-NMR, GC-MS) in the characterization of degradation products. The combination of advanced technical and regulatory capability positions Intertek ASG ideally for such studies.

Intertek ASG's experience in the characterization of complex molecules and formulations gives a special benefit to customers working with novel products where it is difficult to predict degradation pathways and where the characterization of degradation products represents a particular technical challenge.

asg.nwtc@intertek.com

+44 (0) 161 721 5247

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