Extractables & Leachables (E&L) Studies – Broad Matrix Expertise
- Extensive experience in E&L studies across diverse drug products and packaging systems
- Proven capability with complex matrices: ointments, gels, oral suspensions, transdermal patches
- Identification of unknown extractables and leachables using HRMS
- Data supporting regulatory submissions and risk assessments
- Testing services with guidances of cGMP, PQRI, USP, EMA.
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. The theme of the work is clear and conveys profound thoughts.
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).”