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Extractables & Leachables

EAG has extensive experience performing container closure qualifications, designing extractables and leachables programs and employing Quality by Design (QbD) principles to inform development decisions and meet regulatory requirements for E&L data in an efficient and economical manner.

Our scientists are armed with decades of trace impurity characterization experience, a large arsenal of mass spec and other instruments and uncompromising resolve. Our state-of-the-art equipment, including HPLC-Orbitrap and Q-TOF mass spectrometers, provide the high-end identification horsepower required for this type of trace analysis.

Experience includes pressurized metered dose inhalers (PMDI), dry powder inhalers (DPI), nebulized vials, syringes, stoppers, vials, infusion sets/tubing, stents, infusion pumps–including primary and secondary packaging challenges regarding VOCs, ink-related leachables and more.

We offer expert program design and regulatory support, employing a well-defined process to optimize your data package while actively managing “scope creep” often associated with extractables and leachables development. We begin by detailing a program customized to the route of administration and unique characteristics of your drug so deliverables, timing and costs are predictable.

  • Designed and executed E/L programs for all types of container closure systems
  • Drafted sections of multiple NDAs
  • Provided strategic program design to respond to time-bound FDA requests
  • Drafted responses to FDA deficiency letters

Submissions for orally-inhaled nasal drug products (OINDP) and injectable solutions generally include a description of potential extractables with a safety assessment and a determination of observed leachable compounds. EAG has conducted studies that provided this data for many drug product types. Multiple products, including two inhalation products, containing extractables and leachables data generated at EAG were approved first round.  All study protocols are based on industry best practices and the new USP <1663> and <1664> chapters.