Extractables and Leachables Testing (USA)
Extractables and leachables analysis for organic and inorganic elements and compounds.
Intertek QTI provides a comprehensive approach to controlled extractables for evaluation of product safety, evaluation of candidate product containers and closures, and assessing and defining vendor specifications. Intertek QTI provides research and classical approaches to extractable and leachable studies.
Extractable and Leachable (E/L) Services:
- Developing and validating methods (HPLC, GC, ICP) for controlled extractables from pharmaceutical containers, closures and devices
- Identification of extractables using GC/MS and LC/MS/MS
- Modifying specific controlled extractables methods for routine E/L testing
- Validation of routine methods for product release
- Leachables profiles
- Validation of leachables methods for use in storage and stability programs
Intertek QTI is FDA and DEA registered, operating in accordance with cGMP regulations and associated guidance documents.
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