Utility Navigation About Locations Contact Menu Home Services PPD® Laboratories GMP Laboratory Services Extractables and Leachables Publications Share this All Services Discovery Early Development Clinical Development PPD® Laboratories Bioanalytical Lab GMP Laboratory Services Small Molecules Biopharmaceuticals Inhalation Services Staffing Solutions Formulation Development Microbiology Testing Extractables and Leachables Mass Spectrometry Organic Synthesis Materials Characterization Method Development and Validation Stability and QC Testing Central Lab Vaccine Sciences Biomarker Services PPD® Laboratories Brochure Post-Approval PPD® Consulting Technology, Innovation & Performance Industry Expertise Events GMP Lab Extractables and Leachables Publications Date: 30 June 2015 | Topic: Extractables and Leachables The evaluation of extractables and leachables (E&L) is an increasingly important component of the pharmaceutical development process. To support E&L testing, we employ more than 40 scientists, maintain 10,000 square feet of laboratory space and utilize state-of-the-art instrumentation that includes GC/MS, LC/MS and ICP-MS systems. Compounds that migrate to the drug product from the manufacturing process components, the final container/closure packaging or product administration components could be harmful to the patient or cause patient safety issues and adversely impact the efficacy of the product. The scrutiny and expectations for evaluating E&L have extended beyond where they were only a short time ago to today where nearly all drug products under development should include some level of consideration for E&L evaluations. These evaluations often extend beyond the primary packaging container/closure with the primary focus and most in-depth evaluations reserved for products with the highest levels of container-to-drug contact and those that include a direct administration route to the patient, such as inhaled and parenteral products. Please enter your contact information below to download recent articles on E&L authored by scientists from PPD Laboratories. Connect With Us We want to hear from you Investigators Needed Register in PPD's Database Stay Connected RSS Twitter LinkedIn Facebook SERVICES Contact Services Discovery Early Development Clinical Development PPD® Laboratories Post-Approval PPD® Consulting Technology, Innovation & Performance Industry Expertise Events THERAPEUTIC AREAS Cardiovascular Critical Care Dermatology Dental Pain Research Endocrine and Metabolics Gastroenterology Hematology & Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Respiratory Urology PARTICIPATE IN A TRIAL Volunteer for a Study Become an Investigator EXPERT COMMUNITY Clinical Trials Emerging Markets Labs Services Therapeutic Areas NEWS & EVENTS PPD In The News News Events Media Kit ABOUT CAREERS SITE MAP Contact Site Map Legal Notices Privacy Policy © 2015 Pharmaceutical Product Development, LLC. All rights reserved. Google+