Nitrosamine Impurities: USP’s Compendial Response - Tools & Resources

Solving Problems That Matter: Nitrosamine Analysis

Expert Insight 3-Part Webinar Series: Upskilling Your Analytical Strategies for Nitrosamine Detection and Control to Proactively Address Safety in Pharmaceutical Product Development.

Unacceptable levels of N-nitrosamine impurities, which may increase the risk of cancer, have been found in some medications resulting in drug recalls, warning letters, and therapeutic shortages. To ensure that the residual level of nitrosamines in your drug products related to your drug development and manufacturing processes is within safe amounts, highly sensitive and specific analytical methods need to be used for the detection, characterization, and quantification of such impurities. Learn how your colleagues have upskilled their lab capabilities and technologies to elucidate the nature of unknown materials in complex drug substances, using a variety of analytical techniques.

In this timely virtual webinar series, pharmaceutical scientific experts discuss key analytical strategies on how to improve methods for nitrosamine impurity detection and characterization, and how sharing this expertise can help your pharmaceutical scientists support your product quality, safety, and efficacy

PART 2 | Nitrosamine Impurities: USP’s Compendial Response - Tools & Resources

Harmful impurities in medicines must be detected and controlled due to the potentially serious risk to public health. Operationally, impurities in drug ingredients or finished drug products can delay product approvals and trigger product recalls, introducing challenges including disruption of business operations, regulatory investigations, and remediation.

The nitrosamine impurities crisis prompted regulators worldwide to increase their scrutiny of drug manufacturing processes even further. This greater scrutiny led to the discovery of nitrosamine impurities in other medicines and later Nitrosamines-Drug-Substance-related-Impurities (NDSRIs). For this reason, manufacturers must understand which medicines are likely to form nitrosamines, how and at what levels nitrosamine impurities are forming, and how to control nitrosamines.

In the following seminar, we will explore how USP responded to the nitrosamine impurities crisis with a proposed general chapter on nitrosamine impurities that provides a risk assessment strategy, methods for detecting and measuring nitrosamine impurities, along with physical reference standards against which manufacturers can compare their test results. Additionally, USP has created a whole suite of resources and tools for stakeholders to face the challenges of Nitrosamine Impurities effectively.

Presenter: Naiffer Romero, MSc, MPH (Principal Scientist, Regulatory Affairs, US Pharmacopeia)

Naiffer has more than 18+ years of pharmaceutical industry experience. In his 10 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with stakeholders and national regulatory bodies. Naiffer is also a certified USP Education instructor.

Most recently, Naiffer joined USP’s Scientific Affair performance cell where he leads scientific outreach and engagement for 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. Naiffer also serves as a member of USP’s Nitrosamine Steering Committee and community host to ‘Nitrosamine Exchange’, a knowledge community on All-things Nitrosamine. Naiffer also liaises technical discussions on pharmacopeial collaboration including the International meeting of World Pharmacopeias (part of WHO).