Separation Science met with Agilent experts to discuss root causes for the presence of nitrosamines in drug substances and drug products, the current regulatory guidance to help identify these mutagenic impurities, the key analytical strategies that can be used to analyze mutagenic impurities, and the role that modern GC/MS instruments can play in routine nitrosamine applications.
Key questions addressed in this interview include:
- What are the identified root causes for the presence of nitrosamines in drug substances and drug products, and what are the current regulatory guidance’s to help identify these mutagenic impurities?
- What are the key analytical strategies that can be used to analyze mutagenic impurities? More specifically nitrosamines in drug substances and drug products to meet the current regulatory requirements.
- How easy is GC-MS for day-to-day nitrosamine applications and are there any precautions that users should be aware of?
- Can you analyze a broad spectrum of nitrosamine analytes using GC-QQQ, as pharmaceutical companies are looking beyond ARB drugs?
- Can you explain why you believe the Agilent GC triple quad is best for nitrosamine analysis?
Experts involved in this interview include Dr Parul Angrish (Pharma Market Manager, Agilent), Dr Soma Dasgupta (Application Engineer GC & GCMS, Agilent), Laurent Pascaud (Product Specialist GC & GCMS, Agilent) and Joel Ferrer (Product Manager GC/TQ & JetClean, Agilent).
The interview forms part of a free-access Technology Guide titled 'Mutagenic Impurities: GC/MS Strategies - Overcoming the Challenges of Trace Nitrosamine Detection and Quantification in Pharmaceutical Products'. To download your personal copy click on the button below...
