The presence of contaminants or impurities in pharmaceutical and consumer healthcare products may lead to undesirable pharmacological and/or toxicological effects, which in turn may affect the safety, efficacy and quality of the product.
Contamination and impurity identification and profiling is therefore critical to the safety, efficacy and quality of a pharmaceutical or consumer healthcare product and is a regulatory requirement.
Impurity and Contamination Centre of Excellence
Our Impurity and Contamination Centre of Excellence are experts in the identification and quantification of trace impurities in a wide range of materials used throughout the global pharmaceutical and healthcare sectors.
We are highly experienced in contamination investigations and the accurate quantification of trace levels of organic and inorganic impurities (down to sub-ppb levels) in materials including:
- Formulated products
We support a wide range of products at the discovery, development and manufacturing stage with the following typical work packages:
- Reaction monitoring, impurity profiling, impurity method development Characterisation
- Defining impurities as Critical Quality Attributes, impurity method validation
- Forced degradation/stability
- Product related impurities safety
- Extractable and leachables
- Foreign particulate matter (counting and characterisation)
- Genotoxic Impurities e.g. N-nitrosodimethylamine (NDMA)
- Process related impurities e.g. surfactants, catalyst residues
- ICH Q3D elemental impurities
- Residual solvents quality
- Troubleshooting - unknown ID and structural elucidation
- Quality control testing and batch release
These services are delivered from our AMS facilities which have been inspected by the UK MHRA for cGMP compliance.