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Minor differences between innovator and generic formulations or in container/closure systems often lead to chemical incompatibility or previously undetected leachables. Discovering these types of problems late in the race for ANDA approval can lead to costly delays, jeopardizing your first-place finish.
ABC Laboratories will help you clear the extractables and leachables (E&L) hurdle in three ways. First, we will help you decide what material for selection of your container/closure system is most compatible with your drug product formulation. Next, our development experts will design the most efficient E&L program based on your drug's formulation, route of administration and container/closure system.
Once your program is designed, ABC's team of E&L experts will apply in-depth knowledge of compound chemistry and decades of E&L experience to deliver the data you need, swiftly and efficiently.
Our talented chemists and polymer scientists have unsurpassed experience in identification and advanced analytical techniques, mass spectrometry interpretation and nuclear magnetic resonance interpretation. Using sophisticated instrumentation such as UPLC, Time-of-Flight (ToF) MS, Ion Trap and LC MS/MS, they have performed hundreds of E&L studies on parenterals, container/closure systems for metered dose and dry powder inhalers, syringes, vials, stents, infusion pumps and other systems. They also test packaging for VOCs, ink-related leachables and more.
In the race to be the first to get your generic compound to market, a good extractables and leachables package can mean the difference between your Abbreviated New Drug Application (ANDA) being "approved" and "approvable" by the FDA. Partnering with ABC Laboratories for your E&L study early in the development process is a smart way to get a head start. |
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