...And Could They Deliver the Data You Need Without Blowing Your Budget?

Extractable and Leachable studies are often straightforward, but they also can be some of the most analytically challenging studies in a development program. Because these types of studies often result in unplanned development challenges, they are difficult to manage from a cost perspective and can often impact  timelines. Let ABC Laboratories help!

The chromatogram shown above represents findings similar to those ABC recently encountered as part of a larger container/closure qualification program. The calculated analytical evaluation threshold (AET) for this product was ~1 ug/can, based on the product label, doses per can and the best practices suggested by Product Quality Research Institute (PQRI). The number of peaks above the AET-required identification (>30), combined with the impurity levels present, posed a signficant analytical challenge—and, as usual, time was of the essence.

Drawing on decades of experience and utilizing a combination of Time of Flight (ToF) and Ion Trap mass spectrometry, ABC's Trace Analysis & Structural Chemistry (TASC) team prioritized, classified and structurally identified 39 peaks of interest in less than 90 days--ahead of time and well within budget.

ABC Laboratories has extensive experience in container closure qualification, designing extractables and leachables programs and employing Quality by Design (QbD) principles to deliver the data regulators demand, in the most efficient and economical manner. We actively manage "scope creep" often associated with extractables and leachables development by detailing a program customized to the route of administration and unique characteristics of your drug--so deliverables, timing and costs are predictable.

ABC has Extractables and Leachables experience with pressurized metered dose inhalers (pMD(), 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.

ABC dedicates some of our most skilled problem solvers to a special team we call the ABC TASC Force. These talented analytical chemists are industry veterans armed with decades of trace impurity characterization experience, a wide array of ultra-sensitive instruments and uncompromising resolve.