Hi, I am Dr Balamurugan K. I am associated with Malladi drugs & Pharmaceuticals Ltd company in India, wherein I am heading Analytical R&D . Being an API manufacturing organization we ensure our products should be free from GTIs and Nitrosamines. We extensively working on Nitrosamines risk assessment and analytical method developments. There were different approaches and understanding across the pharma industry on Nitrosamines however things got evolved based on the guidelines introduced by USP & European Medicines Agency helped a lot however still need a lot of clarity.
I am happy to be part of the community wherein we can learn and share our knowledge/ experience
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Hello everyone,
I am Divyesh Detroja, working as a Manager in Analytical R&D since 2011. I wish to be a part of this trending forum and will be posting my questions and ideas about Nitrosamines for better understanding.
Regards,
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Hi, my name is Danish Khalid. I am from Pakistan. I am currently working pharmaceutical company as a chemist. I started work in pharmaceutical company since 2018. I did my graduation in chemistry. i have expertise in analytical Section such as Method development, Method Validation, Design drug formulation as per innovator. I love to work in Drug discovery and development section. its a great platform to enhance your knowledge. thanks for welcoming
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I am Pooja Bharatiya and I am excited to join this community of professionals. I work with Urban Viadhya, an active ingredients distribution company. I am here to learn from all of you and connect with professionals in the pharmaceutical industry.
I have a lot of experience and expertise to offer, and I am looking forward to contributing to this community. Thank you for welcoming me .
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Hi Im Gangaraju , working in Lupin Limited as Senior Manager-Process development.
Thankful for this platform to get updated on current quality requirements.
Time to time tracking FDA guidance & EMA Q/A will definitely guides industry to move forward.
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Hi All,
My name is Serdar Bilgesoy. I live in Istanbul. I work in Thermofisher as the Global Product Manager of LC Columns. We closely follow up on Nitrosamine topics worldwide and try to support our customers with our unique solutions like mix-mode chemistry columns combined with Orbitrap HRMS. I am so happy to be part of this community, and I hope I can be useful in solving some challenges.
Thank you.
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Hello! I’m Dr. Hardik Patel, Director Molsyns Research.
Nice to meet you all in this forum. Today nitrosamine impurity is most important area where we all need to work together for patient’s safety. Thank you @Naiffer_Host and USP team for creating a platform where we can share knowledge and use it for our society.
We at Molsyns Research, synthesizing drug impurities and supplying to our clients. Currently one of the our dedicated team is working on synthesis of N-nitroso (NDSRIs). We have synthesized many nitrosamine impurity including NDSRIs in mg level to gms level.
Will share list of probable NDSRIs which can be synthesized.
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Hi, I am pradeep kumar Gollapudi, I am associated with Dr.Reddy’s Laboratories , Global Pharmaceutical company in India ,working as an Analytical specialist , IPDO API Analytical R&D . Being API & DP manufacturing organization we ensure our products should be free from GTI’s and Nitrosamines. We are extensively working on Nitrosamines risk assessment and analytical method development and the validation of product related nitrosoamines and general nitrosoamines .There were different approaches and understanding across pharma industry on Nitrosamines however things got evolved based on the guidelines introduced by FDA & EMA which helped a lot however still it needs a lot clarity in limits fixation and control stratagies in API developments.
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It’s a pleasure to be in this forum. My name is Jacqueline Fernández, I am currently in charge of quality control in a pharmaceutical laboratory in the Dominican Republic. I have more than 6 years of experience in quality control in the pharmaceutical industry. I’m here because I really found it an interesting topic and I want to be informed about the new news.
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Hello everyone.
I’m Mark and I work for a large pharmaceutical company.
My role is to look at the various means of decreasing levels of any nitrosamines that may potentially form from APIs within products, through any means necessary.
I’m new to the nitrosamines problem, but have 20+ years experience in the pharmaceutical industry as an analyst, formulator and numerous other aspects.
Hopefully membership here will help in gaining new ideas, or ruling out things that have already been tried and speed up any development process.
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Hello to everyone in the group here. I’m Antonia 
and I work as a marketing manager at Waters in the pharmaceutical area. After having worked in analytical testing labs within drug development I have become very interested in the area of impurities particularly Nitrosamines and find this group very useful for keeping up to date with the latest in the area. In my work as a marketing manager at Waters corporation I am always looking at ways that we can work with analysts and regulatory bodies to facilitate the analytical methodology aspects and ensuring labs are armed with the best tools and simple solutions to meet those requirements now and in future. Mass spec may seem daunting to new users but it is actually very simple and also alot of fun 
#KeepCalmandMassSpec!
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Hi Everyone,
My name is Marko Susla and I am currently working as a scientist with NJ Laboratories, a contract testing laboratory. My background is quite varied. I started my career with Big Pharma where I had the opportunity to spend time with Health and Safety doing Industrial Hygiene Chemistry. Air samples for potent oncology API’s though surface testing to mitigate exposure and special projects. The second half of my career continued with Generic Pharma, API and finished product. I am currently involved in contract testing.
Being in a contract testing organization places me in a unique opportunity since for any given compound or analyte, I never know what the matrix will be until a sample arrives. I started working with Nitrosamines, GC/MS/MS for now, since mid 2022. I have not had the opportunity to start with our LC/MS/MS as yet, but I hope to in the future. We have also converted to Hydrogen as a carrier gas just prior to starting my work with Nitrosamines. Looking forward to participating in the Nitrosamine Exchange community.
Thank you everyone!
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Halo,
This is Dr Parag N Gadkari VP Analytical R & D I am handling All Analytical Functions in Inventiahealthcare Ltd. We are into Generic Formulation Development having presence Globally having Approvals of NDDS formulations across USA & Europe
Hello All:
Greeting. I am Dr.Prabha Maheswaran. I am currently working as a Assistant General manager in Chromachemie Laboratory Private Ltd. I am dealing with the computational in silico studies on the nitrosamine impurities.
Thank you.
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@prabham Welcome to USP Nitrosamine Exchange community. I hope you find insightful and rich conversations and discussions happening in the community. I’m somewhat intrigued by your work on the computational assessment of Nitrosamines. Can you share a bit more?
Hi,
Myself Prashant Darode working in Lupin R and D Nitrosamine and impurity identification expertise.
Thanks and glad to meet you all.
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Hello and thank you for allowing me to be a part of this group!
I’m Matt Hulbert and I’m a consultant (through my firm Biopharm Forge LLC) to the life science industry, focusing on internal risk and quality management systems and on inbound supply chain. I’m currently the go-to person to address nitrosamine issues for two organizations. For the several months I’ve been privileged to be a member I have found your contributions to be an enormous help in my tasks and alert me to information I might have been slow to discover. THANK YOU!
Matt
Hello everyone,
I am Azik Kanadi, PhD, an experienced Regulatory Officer and Pharmaceutical Quality Assessor at the National Agency for Food and Drug Administration and Control (NAFDAC). NAFDAC is Nigeria’s apex Medicines Regulatory Authority. I feel privileged to have joined this community which I termed a repository of knowledge on everything nitrosamines impurities. This will positively impact on my present duties. I am therefore open to learning and willing to contribute to discussions on the platform. Thank you.
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@Azik welcome to our Nitrosamine Exchange community. I hope you find the information and knowledge insightful. We hope to learn more about NAFDAC and the regulatory landscape of Nitrosamines in the agency. Welcome!
Hi everyone. I’m Tatenda from Zimbabwe, working in generic drug manufacturing and recently started a new role in QA, where the issue of Nitrosamine impurities is one of the main focus areas. I hope to learn more about implementing a risk mitigation strategy and/ testing procedure to satisfy the current and future regulatory requirements.
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