Address nitrosamine risk mitigation with confidence
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.
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.
Learning objectives:
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.
Industry-leading API portfolio and formulation expertise
With over 70 years of experience, dsm-firmenich produces reliable vitamin APIs and excipients in GMP-certified facilities. Trust our pharmaceutical grade ascorbic acid and alpha-tocopherol excipients.
Scientific knowledge
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.
Regulatory insight
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.
Ascorbic acid, and other nitrite scavengers, have been shown to act as functional excipients in drug products that can reduce nitrosamine formation by blocking nitrosation reactions.
Discover the latest insights on nitrosamine risk mitigation presented by dsm-firmenich during an eChalk Talk hosted by the American Association of Pharmaceutical Scientists (AAPS).
In this AAPS e-chalk talk dsm-firmenich experts discuss key considerations for nitrosamine mitigation in drug products using nitrite scavengers.
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