Extractables & Leachables Studies

During manufacturing of food products, beverages, pharmaceutical drugs and medical devices, many compounds are intentionally added as colorants, coatings, impact modifiers while others may be picked up inadvertently during processing or may be a by-product of degradation during storage, transportation or sterilization. The Extractables and Leachables (E&L) testing identifies chemical compounds that could be potentially harmful to end users, and is an essential pre-requisite according to regulations.

With close to two decades of experience in E&L testing, VIMTA has been the pioneer and most preferred testing partner in this domain. Our state of the art laboratories are equipped with LCMS/MS, GCMS and ICPMS to accurately identify the chemical compounds that may leach from the product during usage. At VIMTA, we offer customized protocol driven E&L testing services to help you ensure that your product complies to applicable regulations and is safe for the patients. Our experienced scientific team has performed more than ~2000 E&L studies for various product categories and is fully conversant with applicable standards and regulatory requirements. Our data has been submitted to, and well accepted by, US and European regulatory authorities.