Nitrosamine Testing In Drug Development: How Pace® Ensures Regulatory Compliance And Product Safety

The pharmaceutical industry is operating under unprecedented scrutiny as global regulators intensify oversight of impurities that can compromise patient safety and product integrity. Among the most concerning are compounds that may form unexpectedly during manufacturing, storage, or even through interactions with packaging materials. Their potential presence — often at levels measured in nanograms — poses both a technical and regulatory challenge, demanding highly sensitive detection methods that do not slow the pace of drug development.

For more than three decades, Pace® Life Sciences has partnered with innovators to address such challenges, applying advanced analytical platforms and deep scientific expertise to safeguard drug quality and compliance. Our experienced teams combine proven methodologies with cutting-edge instrumentation to deliver results that sponsors can trust throughout the product lifecycle, from discovery through commercialization.