Coffee Chat: the analysis of nitrosamines
This discussion will focus on the analysis of nitrosamines and the consequences of the ‘nitrosamine crisis’. Since 2018, genotoxic impurities have affected several drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. This issue has resulted in regulatory actions and loss of revenue for the manufacturers. Amid this crisis, companies realized the need to address the wider issue of active pharmaceutical ingredient quality for drugs currently on the market including the accurate identification, quantification and monitoring of impurity levels.
Our experts will discuss the different methods that can be used to detect nitrosamines, as well as explaining how the highest levels of sensitivity can be reached.
What will you learn?
- What are nitrosamines and why is it important to quantitate them?
- What contamination sources are currently being analyzed for potential impurities?
- What methods are used to detect nitrosamines?
- What are the challenges have you faced when analyzing nitrosamines and how have you overcome them?
- What can we expect in the next 5 years?
Speakers
Daniel Nicolau
Senior Scientist
Reading Scientific Services Ltd (Reading, UK)
BM Rao
Head – QA for Emerging Markets
Dr Reddy’s Laboratories (Hyderabad, India)
Dr BM Rao owns a PhD degree in Chemistry and has about 31 years of work experience in pharmaceutical analytical R&D, quality control and assurance functions in reputed organizations including Janssen (pharmaceutical companies of Johnson & Johnson; Mumbai, India), Novartis (Hyderabad, India), Zydus Cadila (Hyderabad, India), Nicholas Piramal (Hyderabad, India) and Dr Reddy’s. He has extensive hands-on experience on analytical instruments/techniques related to chromatography, spectroscopy and thermal analysis etc. He has exposure to various regulatory audits including USFDA, EMEA, TGA, Health Canada etc. and has worked with reputed international consultants in QC remediation. He has about 80 scientific publications in reputed peer reviewed national/international journals and successfully guided eight PhD students.
During his professional career he has been recognized for his contributions at work and won awards including ‘Chairman’s Excellence Award’ from Dr Reddy’s (Feb 2018 & Jan 2003), ‘Standards of Leadership’ from J&J at Janssen, Mumbai site (year 2010) and ‘Best New Leader Award’ at SAI Life Sciences Limited (year 2013). He has extensively travelled to USA, Mexico, Europe, Germany, Belgium, Singapore, Brazil and Malaysia and interacted with several big and emerging biotech pharmaceutical analytical and quality experts.
Since September 2015, Dr BM Rao is working as Head of Quality for Emerging Markets, Analytical Science & Technology (ASAT) & Corporate Quality control at Dr Reddy’s Laboratories and providing technical leadership to the analytical method validations/transfers and quality control labs of APIs and formulations.
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