Nitrosamines in Drug Products: Where Are We Now?

Since 2018 when the presence of Nitrosamines was first reported in several ARB (angiotensin II receptor blocker) drugs, there has been increasing regulatory focus to mitigate the presence of these potential human carcinogens in drug substances and drug products.

Who Should Attend:

• Anyone with an interest in, or challenged by, the analysis N-Nitrosamines and Nitrosamine Drug Substance Related Impurities (NDSRI) in API and/or Drug Products

• Analysts and Scientists working in the Pharmaceutical and Generic Pharmaceutical industries.

Key Learning Points:

• Review the latest regulatory updates (FDA and EMA)

• Learn about published LC-MS/MS applications which address the N-Nitrosamines and NDSRI analysis challenges in drug products

• Find solutions to sample preparation challenges for N-Nitrosamines analysis in drug products

• Obtain examples of specific Phenomenex applications for nitrosamines (10 mutagenic nitrosamine impurities in Acyclovir) and NDSRIs (N-nitroso propranolol in a propranolol drug substance and product)

Presenter: Phil Koerner (Market Development Manager, Pharmaceuticals)