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Cutting Edge

High Five- January

With the evolution in tandem-mass spectrometry coupled with liquid chromatography, the LCMS platform has become the workhorse of analytical chemistry, with applications ranging from studying the outer space to exploring the building blocks of life. Shimadzu’s passion for innovation has led to ground-breaking developments and breakthrough research in MS technology. As a leading MS technology and service provider, we are proud to be a part of an amazing community of passionate MS researchers. In this new column, High-5, we bring to you exclusive interviews with leading MS Scientists and our esteemed customers, on their workflows and the road ahead for MS.

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Virupaksha was established in 2003 with headquarters in Hyderabad. From a single manufacturing unit, the company was expanded to four units with over900 employees and has a large customer base of over 300 customers with a presence in over 100 countries. M. Nagarjuna Reddy completed his B.Tech., Chemical Engineering and joined Virupaksha Organics as a Director in 2016. He got trained at IIT on Flow Chemistry and has undergone a special course on procurement management from Indian School of Business (ISB), Hyderabad.


What is your main field of research?

Virupaksha group of companies was established in 1997 by Dr. G. Chandra Mouliswar Reddy with operations at Hyderabad and Humnabad and is among the first in India to focus on providing high end Contract Research and Manufacturing (CRAMS) of advanced intermediates and APIs covering various therapeutic areas including antihistamine, antifungal, analgesic, antidepressant, antiasthmatic, cough suppressant and antidiabetic drugs. We are one of the global leaders in supplying advanced intermediates and APIs to domestic and international pharmaceutical companies for generic markets across the world. We are proud to inform that Virupaksha Organics Limited Unit-I at Hyderabad has been approved by US FDA, PMDA (Japan), KFDA (South Korea) and other regulatory bodies.


What are the current trends with regard to the use of LC-MS/MS systems in your industry?

LC-MS/MS plays a major role in the development of new pharmaceutical products; it is highly useful in identifying and quantifying impurities in pharmaceuticals. Continuous improvements in mass spectrometry have resulted in wider applications such as analysis of genotoxic impurities, nitrosamines, structural elucidation of unknown impurities arising in regular R&D samples, etc., besides Drug Substances with similar structure can be separated and characterized with high degree of confidence using LC-MS/MS. Pharmaceutical industry is among the key end users of LC-MS/MS due to high sensitivity levels in accordance with modern stringent regulatory guidelines for drug development and safety.


How are you utilizing the Shimadzu LC-MS/MS System for your day-to-day activities?

We have used LC-MS/MS for analysis of nitrosamines and genotoxic impurities in various pharmaceutical products and intermediates like Fexofenadine HCl, Fluconazole, Bilastine, Tramadol HCl, Escitalopram Oxalate, Citalopram HBr etc., as per US FDA and EDQM guidelines. Besides the system helps in meeting the challenging requirements on the limits established by regulatory agencies through the analysis of various samples such as raw materials, in process samples and finished products etc.


What are your expectations from Mass Spectrometer technology in the future?

Pharmaceutical production demands extensive use of APIs while facing numerous challenges in assuring quality and compliance. As we are analyzing more samples, we are expecting shorter times for analysis than the current work flows. Mass spectrometer is used for the determination of nitrosamines and genotoxic impurities in API molecules and hence has a vital role to play in pharmaceutical regulatory activities and we are looking forward to develop and validate the analytical methods faster.


Please share your experiences on support and service from Spinco Biotech?

Spinco Biotech provides excellent service support with high level of commitment and service. They offer immediate support during service calls and help us to meet the defined time lines. During the pandemic lockdown they have extended services without any break, we are thankful for the services and support they given and wish them to best for all their good future.