Is Your Drug Formulation Reacting with the Bag?
Unexpected Precipitate or Haze? It Might Be the Container.
Visual or chemical instability doesn’t always start with the formulation, often, the container is part of the problem. This is especially true in complex biologics, cell therapies, or sensitive small-molecule products, where even subtle incompatibilities can lead to haze, particulate, or degradation.
At Gateway Analytical, we specialize in identifying the root cause of these interactions. Our expert team uses advanced chromatographic techniques, including LC-MS/MS, GC-MS, and high-resolution QTOF-MS, to detect and characterize leachables, degradation products, and other reactive byproducts. We go beyond detection to provide actionable insight into how your drug product interacts with its packaging system in real-world conditions.
Our compatibility investigations are rigorous, responsive, and supported by direct communication with the scientists conducting your study. Whether you’re addressing a sudden change in stability or seeking proactive risk mitigation, Gateway provides the scientific clarity and regulatory alignment you need.
Submit your sample for compatibility investigation. Speak directly with our team about your packaging concern!
Gateway Analytical ensures your products meet regulatory demands, protect patients, and reach the market with confidence. Let’s advance safety together. Contact us at (724) 443-1900 or in**@***************al.com.
