Nitrosamines

Solving Problems That Matter - a Waters webinar series featuring USP speakers

Episode 9: Nitrosamines

When present in pharmaceutical products, nitrosamine impurities - a probable carcinogen - can disrupt drug supply chains and lead to shortages resulting from product recalls and withdrawals.

Join our panelists Naiffer Romero from the USP and Marian Twohig from Waters Corporation as they address analytical challenges in the detection and control of nitrosamines and Nitrosamine Drug-Substance Related Impurities (NDSRIs).

**Key learning objectives: **

• Understand the current analytical challenges associated with the detection and control of nitrosamine impurities. Explore fit-for-purpose and compliant-ready LC-MS-MS solutions for the cGMP laboratory.

Who should attend:

• Pharmaceutical scientists involved with the detection and control of nitrosamines impurities

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

Naiffer has more than 20 years of pharmaceutical industry experience. In his 13+ years tenure with USP, he has served several roles: Lead scientist in the dosage form performance laboratory, reference standard development team, Manager in charge of LATAM Compendial engagement and education, responsible for stakeholders and national regulatory bodies engagement. Naiffer is also a certified USP Education instructor. Most recently, Naiffer joined USP's Scientific Affairs performance cell, where he leads scientific outreach and engagement for LATAM & U.S. 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 in All-things Nitrosamine. Naiffer also liaises technical discussion on pharmacopeial collaboration, including international meetings of World Pharmacopeias (part of WHO).

Presenter: Marian Twohig, Ph.D. (Consultant Scientist, Waters Corporation)

Marian has over 20 years of experience supporting quantitative and qualitative applications in the pharmaceutical, food and environmental and materials science industries. She works as a Consultant Scientist for Waters Corporation where she has previously held several Senior Scientist positions. Currently, the focus of Marian’s work is in the development of quantitative analytical methods to meet the needs of the pharmaceutical industry. She is particularly interested in chromatographic separations and the application of combining low- and high-resolution mass spectral data with other chemical information for identification of unknown chemical entities. Marian holds a Ph.D. in Analytical Chemistry from Munster Technological University, Cork, Ireland.

Moderator: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.