Our Extractable and Leachable (E&L) Studies are designed to assess the safety and compatibility of packaging materials, container systems, and medical devices with pharmaceutical products. These studies ensure that no harmful substances leach into your product, maintaining its safety, efficacy, and regulatory compliance.

We perform rigorous testing to identify and quantify potential extractables and leachables, including:

• Materials used in packaging systems, containers, closures, and devices
• Identification and quantification of organic and inorganic compounds
• Evaluation of the impact on drug stability, safety, and performance
• Compliant with FDA, EMA, and USP standards

Using advanced techniques such as GC-MS (Gas Chromatography-Mass Spectrometry), HPLC (High-Performance Liquid Chromatography), and ICP-MS (Inductively Coupled Plasma Mass Spectrometry), we provide thorough and reliable results to ensure that your product’s packaging materials meet the highest quality, safety, and regulatory standards.