Extractable & Leachable
- Extractables and Leachables study is to demonstrate that potentially harmful or toxic impurities migrate from packaging component into a drug product during its expected self-life period. Extractable and leachable study can assist to identify the potential source of leachable by means of controlled extraction studies which give a profile of extractable components. Antioxidants, plasticizers, dyes, metal catalysts, polymer and degradation products are potential source of Leachables. QbD has taken up E/L studies for a wide range of drug products in a variety of packaging types, which include Injectable, transdermal ointment & patch, ophthalmic solution & suspension, and oral solution.
- QbD provides extractable and leachable testing services in accordance with regional guidance and nationally/internationally recognized standards including Good Manufacturing Practice (cGMP), Product Quality Research Institute – PQRI extractables and Leachables guidelines, United States Pharmacopeia (USP) requirements (e.g., USP extractable and leachable USP chapters and ), European Medicines Agency (Extractables and Leachables EMA guidance).”
