Process Impurities and Reference Standards

Using disclosed or deduced process chemistry routes, our synthesis chemists and analysts work closely as a team to:

• Propose likely structures for process impurities based on analytical data in combination with an understanding of the mechanism for their formation
• Rapidly reject unpromising putative structures
• Confirm the identity of the proposed compounds by rapid synthesis and comparison of retention times
• Shorten the cycle time between proposing and confirming process impurities to avoid loss of time and wasting resources synthesising incorrect structures
• Purify the validated compounds as analytical standards and provide a certificate of analysis for use by the study director or principal investigator

Degradation products and metabolites

Selcia has experience working with complex matrices and interpreting data from multiple analytical techniques. From knowledge of likely sites of metabolism, our synthesis chemists and analysts work closely as a team to:

• Propose likely structures for metabolites based on analytical data
• Rapidly reject unpromising putative structures
• Confirm the identity of the proposed compounds by rapid synthesis and comparison of retention times
• Shorten the cycle time between proposing and confirming process impurities to avoid loss of time and wasting resources synthesising incorrect structures
• Purify the validated compounds as analytical standards and provide a certificate of analysis for use by the study director or principal investigator

Analytical Support

The services available from our MHRA accredited GLP analytical laboratory include:

• NMR (to GLP if required) for structural confirmation and comparison with standards and full interpretation and structural elucidation
• Analysis (to GLP if required) including mass spectrometry and infrared spectroscopy
• All custom prepared products are available with a certificate of analysis (to GLP if required)
• Non-routine analytical studies including structural elucidation and impurity profiling at microgram levels using capillary NMR