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Generally, orally inhaled and nasal drug products (OINDP) and parenteral and ophthalmic drug products (PODP) are the most common drug products at high risk of leachables.
"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.
OINDP Leachables and Extractables Working Group, August 2006, Product Quality Research Institute (PQRI)
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