Extractables and leachables testing
Recommendations for Extractables and Leachables Testing
Extractables and Leachables (E&L) testing provides vital information concerning the potential for impurities deriving from container closure systems, drug delivery devices and manufacturing processes.
This contamination can present a risk in terms of both patient safety and product efficacy.
With an array of modern technologies, knowledge of regulatory issues and complimentary CMC analytical capabilities, we are your ideal partner for extractables and leachables testing.
Extractables and Leachables studies utilise organic and inorganic screening methods to profile extractables from polymeric componentry, see the table below for examples, and target leachables in final drug product formulations.
|Drug Container / delivery devices|
|Vials, ampoules and bottles|
|Process components and consumables|
Our expert dedicated Extracables and Leachables team designs bespoke study protocols in accordance with the latest regulatory guidelines to ensure drug product safety and compatibility with storage and delivery devices.
- Extraction under exaggerated or simulated use conditions
- Accelerated leachable studies
- Screening and compound specific validated assay methods
- Characterisation of unknowns
- Toxicological assessment (using our partner provider)
All testing is performed at our cGMP facilities in the UK as part of our Impurity and Contamination Centre of Excellence.
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.
Our expertise in assessing extractables and leachables testing includes: