Impurity and Contamination Centre of Excellence
Our Impurity and Contamination Centre of Excellence comprises two UK laboratories, which are regularly inspected by the UK MHRA for cGMP compliance.
• Detection of a full range of potential nitrosamine impurities
• Organic impurity characterisation and structural elucidation
• Inorganic trace analysis
• Extractable and leachable testing
• Contamination and foreign particulate analysis
We support the regulatory Chemistry, Manufacturing and Control (CMC) compliance of your drug substance and drug product through the complex challenges faced in drug development, solving issues at all stages of manufacture.
The Next Chapter in Nitrosamine Testing
From recent experience we have seen a significant increase in requests related to API related nitrosamines.