Navigating nitrosamine risk mitigation is an unprecedented challenge for the pharmaceutical industry. We are here to provide high quality antioxidants and technical expertise to help you succeed in addressing nitrosamines in your drug products. Ascorbic acid has proven efficacy in scavenging nitrites and preventing nitrosamine formation in a model formulation, in concentrations as low as 0.25% and is a safe and easy-to-use solution in direct compression or wet granulation processes.
Our new clinical research unveils compelling evidence of ascorbic acid's remarkable ability to scavenge nitrites and inhibit nitrosamine accumulation, even at concentrations as low as 0.25%. Download our latest scientific poster to explore this promising method of mitigating nitrosamine risk in pharmaceuticals.
Pharmaceutical companies must assess and control nitrosamine content in their drug products. Solutions are often multi-layered and may include simple and safe nitrite scavengers in the final drug formulation. In this session, Anne-Cécile Bayne Ph.D., Global Science and Innovation Lead Pharma at dsm-firmenich, outlines key considerations for nitrosamine mitigation using nitrite scavengers with emphasis on ascorbic acid.
Overcoming critical formulation challenges takes more than adding ingredients – it takes a reliable partner. Whether it’s supporting you with the reformulation of your existing drug product, or helping to bring new innovative therapies to market, we can assist you in implementing a proven mitigation strategy to reduce the risk of nitrosamine formation in your pharmaceuticals.
dsm-firmenich has more than 70 years of experience in producing and securing the supply of vitamin APIs and excipients. Manufactured in GMP-certified facilities, our pharmaceutical grade ascorbic acid and alpha-tocopherol excipients are ingredients you can trust.
We have the scientific know-how and cutting-edge technology you need to mitigate the risk of nitrosamines in your oral solid, semisolid, liquid or injectable formulations.
Our excipient production is governed by a wide range of global certification systems to support the success of your pharmaceutical solutions, including GMP, CEPs, DMFs and compliance with multiple pharmacopeia.
dsm-firmenich is global company with a global footprint and strong local knowledge.
