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.
With looming deadlines set by governmental bodies, all 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 AAPS e-chalk talk dsm-firmenich experts discuss key considerations for nitrosamine mitigation in drug products using nitrite scavengers.
This session lasts 30 min.
Our latest whitepaper explores the current nitrosamine regulatory climate that the pharmaceutical market is facing. Formulators are now confronted with new guidelines that may lead to the reassessment of certain drug formulations at risk of nitrosamine formation. As a critical priority for global agencies, developing nitrosamine mitigation strategies is imperative for the safety of future pharmaceuticals. Ascorbic acid and alpha-tocopherol could be the answer to developing risk-free formulations.
Nitrosamines are potential mutagens and need to be controlled in human drug products. Recently, nitrosamine contamination of high-profile drugs has prompted numerous recalls, and increased regulatory assessments for marketed products, as well as for new drug applications. Learn from leading experts how antioxidants in drug formulation can minimize the risk of nitrosamine formation.
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.