Leachable materials may originate from pharmaceutical container closure systems, process equipment, medical device packaging, and migrate to contaminate products. Extractable and Leachable (E/L) studies to identify and quantify these compounds, ensuring the quality and effectiveness of the drug product. A full-service extractable and leachable testing program also helps you to fulfil the regulatory requirements.
Evaluating the impact of extractable and leachable compounds on safety of the drug product interaction is of utmost importance to protect the patient safety and comply with regulations.
Our extractable and leachable services include:
Selection of container closure system (CCS) for dosage forms and medical devices.
Design, develop and execute the E&L study for pharmaceutical industry according to the various regulatory guidelines and recommendations such as USFDA (USP <1663> and <1664> General Chapters), EMA, PQRI, ICH and/or customer requirements.
Ink / Gum migration studies
Glass delamination studies
Techniques used are GC-MS/MS, HS-GC-MS, LCMS, IC and ICPMS; soxhlet extraction apparatus and others for samples processing.
Primary Containers, Auxiliary Articles and Manufacturing Aids used for various drug products such as Solids, Parentals, Injectables, Ointments, Lotions, Syrups, Suspensions, Gels, Inhalations, Creams & Emulsion, Transdermal Patches etc.,
