AnalyteGuru continues its Networking in Science webinar series with Naiffer Romero, Senior Scientific Affairs Manager, MSc, MPH, United States Pharmacopeia (USP), on May 24 at 10 a.m. CDT. In this webinar, Romero will share how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources that provides a risk assessment strategy.
Nitrosamines, or more correctly N-nitrosamines, refer to any molecules containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens.
Why is nitrosamine impurity analysis in drugs important?
In July 2018, elevated levels of nitrosamines were detected and reported in certain pharmaceuticals and led to the recall of many affected drug products. Such recalls are undesirable to pharmaceutical companies, because they can lead to extra costs, revenue loss and impact the manufacturer’s reputation.
The unexpected finding of nitrosamine impurities in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk of containing their presence. Stringent regulatory guidance is not only helping to make drugs safer, but through method requirements are helping laboratories to identify the appropriate tools needed for accurate and confident analysis.
The nitrosamine impurities crisis prompted regulators around the world to increase their scrutiny of drug manufacturing processes even further. In the future, this greater scrutiny may lead to the discovery of nitrosamine impurities in other medicines. For this reason, manufacturers need to understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines.
United States Pharmacopeia’s (USP) response to the nitrosamine crisis
During this webinar, Romero will explore how USP responded to the nitrosamine impurities crisis not only with a proposed general chapter on nitrosamine impurities but also non-compendial resources and tools that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities. In that effort, USP built a knowledge community dedicated to all things nitrosamines.
What you can learn from this webinar
How and at what levels nitrosamine impurities are forming, and ways to control them
The importance of shared community in overcoming the challenges with nitrosamine analysis
Tools that provide a risk assessment strategy, methods for detecting and measuring nitrosamine impurities in pharmaceutical APIs (active pharmaceutical ingredients) and drug products
Naiffer Romero Senior Scientific Affairs Manager, MSc, MPH United States Pharmacopeia (USP)
Naiffer Romero has more than 18 years of pharmaceutical industry experience. In his 10-year tenure with USP, he has had a variety of roles.
Most recently, Romero joined USP’s Scientific Affairs performance cell where he leads scientific outreach and engagement for the LATAM & US region on key national health priority topics. His combined pharmaceutical expertise includes analytical development, salt and polymorph selection, development of dissolution methods, IVIVC modeling, and impurity analytical strategy.
Romero also served as member of USP’s Nitrosamine Steering Committee and community host to “‘Nitrosamine Exchange,“ a knowledge community in all-things nitrosamine.Additionally, he also liaises technical discussions on pharmacopeial collaboration, including International meeting of World Pharmacopeias (part of WHO).