ExtLe Solutions Limited designs and manages Leachables Studies that are individually tailored for clients’ products.
Studies are designed to utilize storage conditions, time points, and analytical methodologies, fully aligned to the current regulatory expectations provided in USP <1664> (& USP <1664.1> for OINDPs).
Analytical methods are developed and validated by our CRO partners, to ensure leachables are detectable at levels equivalent to relevant safety thresholds. Methods can be specific for named leachables, or can be developed to be more general and ‘screening’ in nature for the determination of
- Volatile Leachables
- Semi-Volatile Leachables
- Non Volatile Leachables
- Elemental Leachables aligned to the guidance provided by ICH Q3D
Where any leachable is observed above a pre-agreed action threshold (defined from the AET, which in turn has been defined from the SCT / TTC / PDE), a full safety assessment will be performed by a qualified toxicologist.
An interim leachables report is produced at each time point, including trending of observable leachables levels, with a final version generated at the end of the study.
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