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.

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The Next Chapter in Nitrosamine Testing

From recent experience we have seen a significant increase in requests related to API related nitrosamines.

Read the article here

LGC Medicine Bottles Tablets