Extractable & Leechables

Our extractable and leachable services include:• Design, develop and execute the E&L study for pharmaceutical industry according to the variousregulatory guidelines and recommendations such as USFDA (USP <1663> and <1664> General Chapters),EMA, PQRI, ICH and/or customer requirements.• Selection of container closure system (CCS) for dosage forms and medical devices.• Elemental Analysis for Glass delamination studies• Techniques used are GC-MS/MS, HS-GC-MS, LCMS, and ICPMS; soxhlet extraction apparatus and othersfor samples processing.