It’s Not Just a Color Shift. It’s a Chemical Clue.
A sudden color change in your gel, injectable, or cream isn’t cosmetic, it’s often an early warning of chemical instability or packaging interaction. Left unresolved, discoloration can escalate into product degradation, batch rejection, or regulatory setbacks. Whether it stems from API or excipient breakdown, pH imbalance, oxidative stress, or reactive leachables from the container system, identifying the true cause quickly and accurately is critical to protecting product quality and patient safety.
At Gateway Analytical, we go beyond surface-level testing. Our Ph.D.-led team delivers in-depth root cause investigations for discoloration issues using advanced analytical platforms including LC-MS/MS, GC-MS, and QTOF-MS. These powerful tools allow us to precisely identify degradation pathways, characterize reactive byproducts, and evaluate packaging or excipient compatibility under real-world conditions.
What sets Gateway apart is not only our instrumentation but also our approach. Every study is supported by direct scientist-to-client collaboration, ensuring transparency, clarity, and actionable results. Our scientifically defensible reports are designed for high-stakes regulatory review, providing the confidence you need for submission and decision-making.
From early-phase investigations to late-stage stability challenges, our team delivers timely insight where it matters most, helping you resolve issues, safeguard product integrity, and maintain your development or commercial timelines.
Submit your sample for root cause analysis today and speak directly with our scientists to discuss your stability 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
