"Extractables are compounds that can be extracted from OINDP device components or surfaces of the OINDP container/closure system in the presence of an appropriate solvent(s) and/or condition(s).
Due to the time-dependent nature of the leaching process, leachables appear in an OINDP formulation over the shelf-life of the product as determined during appropriate stability and accelerated stability studies.
The Recommendations are divided into two main parts, which cover these topics: (i) the derivation and justification of safety thresholds, and (ii) best practices for extractables and leachables studies in pharmaceutical development programs for OINDP. The key conclusions and recommendations are listed below.
* Scientifically justifiable safety evaluation and qualification thresholds for leachables in OINDP can be established.