Global regulatory bodies, including the FDA and EMA, have introduced a legal obligation for drug manufacturers to implement mitigation strategies that aim to minimize the risk of nitrosamine formation in drug products.
The addition of antioxidants to drug formulations is a safe and viable, FDA-recommended mitigation strategy for inhibition of nitrosamine formation in drug products. Prevention of formation of potentially carcinogenic impurities is possible with commonly used ascorbic acid and alpha-tocopherol.
When added to your formulation as excipients, ascorbic acid and alpha-tocopherol bring multiple benefits, including:
Nitrosamine risk mitigation is a huge challenge for drug manufacturers and the wider pharmaceutical industry. Extensive formulation and regulatory knowledge as well as a comprehensive understanding of the active pharmaceutical ingredient (API) and manufacturing processes is crucial to bring safer drug products to market.
Discover how dsm-firmenich can help you navigate nitrosamine risk mitigation through our reliable customized solutions and expert services.
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 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 is global company with a global footprint and strong local knowledge.
