Nitrosamines: Why Is Column Chemistry Critical?

Nitrosamines have been compounds of interest to the pharmaceutical industry in recent years due to the mutagenic nature of these impurities. N-Nitrosodimethylamine (NDMA) was the first of these impurities to be highlighted as hazardous to human health. Eventually, the list expanded to many nitrosamines in various drug substances and drug products.

More recently, nitroso drug substance-related impurities (NDSRI) became a major concern for the industry. As per regulations, any possibility for formation of nitroso impurities during synthesis or the manufacturing process of the drug substance must be evaluated, and steps must be taken to identify, quantify, and minimize or eliminate such impurities. Therefore, analytical laboratories require robust methods for detection and quantitation of these impurities.

By attending this webinar session, you will understand:

• What nitrosamines are and why they have been discussed in recent years
• Which parameters are critical in nitrosamine analysis in pharmaceutical drugs
• What nitroso drug substance-related impurities (NDSRI) are and why it is critical to evaluate and eliminate these impurities
• Why selectivity is too critical in nitrosamine analysis
• Why the presence of alternative chemistries is crucial in handling current and upcoming nitrosamine challenges
• The impact of column dimensions in achieving optimal chromatography for nitrosamines
• How different Agilent LC chemistries help in developing robust methods for nitrosamines
• The best practices for nitrosamine analysis

Presenter: Manu Grover (HPLC Columns Business Development Manager, Agilent Technologies, Inc.)

Postgraduate in Pharmacy from Manipal Academy of Higher Education, India

• Have more than 21 years of chromatography experience
• Have worked in field of Manufacturing and Analytical Research to support IND, NDA and ANDA filings in pharmaceutical companies like Dr. Reddy's, > > - Panacea Biotec & Ozone Pharmaceuticals.

During the Professional journey have:

• Developed and validated many analytical methods on HPLC, GC, Particle sizing, DSC, pXRD, LC/MS etc.
• Successfully filed multiple analytical Dossiers in US and EU market.
• Filed analytical methods to USP
• Transferred analytical methods
• Handled multiple US-FDA audits
• Trained many scientists on “Data integrity and compliance” during sessions organized by Pharmexcil-Govt. of India

The current role with Agilent sales team and pharmaceutical scientists share market updates, trends, expertise related to Agilent portfolio of columns and supplies. Also, ensure effective implementation of Agilent solutions in the lab.

Presenter: Chander Mani (Field Technical Specialist-LC Columns, Agilent Technologies, Inc.)

After completing M.Sc. (Hons.) in Chemistry at Punjab University, Mr. Chander Mani started his career at Panacea Biotec in Analytical & Bioanalytical department of new drug discovery research and developed several methods for analytical and bioanalytical, and ADME/DMPK related studies. He also worked for several LC-MS based methods for the analysis of textiles and environmental analytes of interests during his stay in Bureau Veritas. For the past more than 10 years at Agilent, Chander has been actively involved in providing LC-MS based application support to pharmaceuticals, food safety and environmental based applications in his various roles. Recently he has worked extensively for Nitrosamine application in various pharmaceuticals using both LCTQ and LCQTOF platforms and published various application notes.