Confidently Analyse Nitrosamine Impurities by GC-MS/MS & LC-MS/MS

Nitrosamine compounds are classified as probable human carcinogens by the International Agency for Research on Cancer (IARC).

Ever since the first U.S. Food and Drug Administration (FDA) notification in June 2018 about levels of these impurities in pharmaceutical API, they have been a reason of continuous discussion globally for analytical scientist, patients and regulators.

After June 2018, the number of recalls and 483’s have been on a rise for not only angiostenin II receptor blockers (-ARB, also called as sartans) but also for other products like Ranitidine, Metformin etc. FDA, European Medicine Agency (EMA) and International Council for Harmonisation (ICH) have constantly set and update the guidelines in measuring impurities in pharmaceutical products. Holistic solution to measurement of nitrosamines need both GC-MS/MS and LC-MS/MS technologies.

Presenter: Dr. Mrunal Jaywant (Senior Director – R & D, USP India)

Presenter: Pravin Makwana (General Manager - QC, J.B.Chemicals & Pharmaceuticals Ltd.)

Presenter: Nilesh Dhamorikar (Director , QbD Research and Development Lab Pvt Ltd)

Presenter: Dheeraj Handique (Deputy Manager-CSC, Shimadzu Analytical (India) Pvt. Ltd)

Dheeraj Handique is working as Deputy Manager-CSC at Shimadzu Analytical (India) Pvt. Ltd. since 2008. He holds a Post-Graduate Diploma in Analytical Chemistry from Bombay Institute of Technology, Mumbai, with total experience of 17 years in analytical field industries.

At Shimadzu, his role involves pre-sales and post-sales application support to pharma, chemical, food safety and flavor and fragrance industry customers pertaining to trouble shooting, tech transfer, method development and validation. His key areas are to suggest complete system configuration with total solution related to GC, GCMS/MS instruments to customers. To his credit he has around 30 posters published in international conferences.

His expertise lies in analysis of drug substances and products, various food matrices, flavor and fragrance matrices with cutting edge technology like GCMS/GCMSMS/HS/TD from Shimadzu with hands on experience on critical sample preparation steps involved. He delivers lectures on Gas chromatography and mass spectrometry, headspace and thermal desorption techniques at various national conferences.

Also, he has been very actively involved in the performance evaluation of various chromatographic and advanced technologies available with Shimadzu like GC, GCMS, GCMSMS, HS, TD etc.

Presenter: Shailendra Rane (Ph.D.) (Deputy Manager-CSC, Shimadzu Analytical (India) Pvt. Ltd)

Dr. Shailendra Rane is Ph.D. in chemistry from Mumbai university and currently working with Shimadzu Analytical (India) Pvt. Ltd. as Deputy Manager CSC since 2008. At Shimadzu, his role involves pre- and post-sales application support to pharma, food safety and bio-similar customers pertaining to trouble shooting, tech transfer, method development and validation. To his credit he has 10 publications in various international journals of repute and around 35 posters he published in national and international conferences.

His expertise lies in analysis of drug substances and products, various food matrices and bio-molecules with cutting edge technology like LCMS/LCMSMS from Shimadzu with hands on experience on critical sample preparation steps involved. He delivers lectures on liquid chromatography and mass spectrometry at various national conferences. Also, he has been very actively involved in the performance evaluation of various chromatographic and advanced technologies available with Shimadzu like SFC, MALDI-ToF etc.

Presenter: Rashi Kochhar Rebello (Manager, Marketing Communications, Shimadzu (Asia Pacific) Pte Ltd)

Rashi has been part of Shimadzu for 13 years now. She has worked extensively with Chromatographic and MS solutions in different capacities. Her expertise lies in supporting workflows for different markets and segments including Biopharma, Pharma and Food. With this background, her current role is to design communication packages for analytical solutions in Shimadzu Asia Pacific.