Hi I am Mijo Stanic,
Owner, CMO and Technical Director of/at Chromicent GmbH in Berlin/Germany.
Chromicent is an analytical service provider in all 3 stages of analytical life cycle management (dev/val/routine and release) and we are GMP-Certified. We also have our own analytical R&D part for the analitical solutions for the future. Since 2018 one of these main topics are the nitrosamines by using SFC-MS/MS and LC-MS/MS. Currently our 3rd publication about nitros is available (I think Naiffer already shared the link). Thank you
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Hi everyone,
Thank you for inviting me.
My name is Marcos Lima.
I work at Pfizer in Brazil in a global area (GTE) as analytical development coordinator.
I was a member at Anvisa in the Working Group on Nitrosamines in 2021 contributing to make the legislation and guideline about this subject.
Best regards,
Marcos
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Hi, My name is Devendra Chavan. I am currently working as a Scientific Liaison-Excipients, at USP India. I am a PhD in Chemistry with a masters degree in Marketing Management. Having 19 years of professional experience, majorly in the field of Analytical Chemistry. Raw material qualification was one of the important aspects of my earlier jobs. Process of testing and qualifying materials for various formulations, has its own unique challenges, especially for excipients. The topic of Nitrosamines in excipients will be a very new area to explore. The subject has just started evolving and still a long way to go. I am happy to be part of this evolution process. Looking forward to interact and gain knowledge on the subject from the subject matter experts, both from industry and academia. Thanks.
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Hi I’m David Elder ex GSK, currently CMC consultant. I have been active in this area since the first reports of NDMA in valsartan became apparent. I’m particular interested in the role of excipients in forming API nitrosamines (rather than the more classic short alkyl chain nitrosamines, e.g. NDMA)
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Hi, I am Bhargava Jana, and working as a scientist in Pfizer, India. I am working in the specialty services department and responsible for extractables & leachables, elemental impurities, impurity identification, and nitrosamines assessment. I am very happy to be a part community. 
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Hi everyone,
My name is lance Smallshaw, you can find out more about me on Linkedin.
I’m Head of Compendial Affairs here at UCB Pharma S.A. in Belgium, I’m based in the Global QA Team for Manufacturing Sites and a member of the Efpia N-Nitrosamines Team. I’m interested all global aspects of N-Nitrosamines.
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Welcome Lance!
Happy to see you being part of this group!
Hi, I am Mohammad Nayef. I am Analytical research head with Hikma, wherein I am heading Analytical department at API plant. Products should be free from GTI’s and Nitrosamines. We are extensively working on Nitrosamines risk assessment and analytical method development from the time being it . There were different approaches and understanding across pharma industry on Nitrosamines however things got evolved based on the guidelines introduced by USP & EMA which helped a lot however still it needs a lot clarity. I am happy to be part of the community wherein can learn and share our knowledge/ experience. Thanks
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Hi,
I am Saumitra Gajjar, Research Associate at Intas Pharmaceuticals Ltd (Biopharma division) . I am working in In-Process group and deal with monoclonal antibodies performing various Analytical Techniques (HPLC) . I have joined this group for interest purpose and to enhance my knowledge. I also want to understand if there is any relations of Nitrosamines with Biologics. A bit early to my career so would like to understand from basics. If any good articles regarding nitrosamine impurities I would definitely like to read. So Looking forward to learn and have scientific discussions
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Hello, I am Jim Sabatowski and am Sr. Advisor at Eli Lilly and Company. I work in our global analytical services group and have been overseeing the method development, validation and testing of commercial drug products for novel API related nitrosamine impurities. Also, I’ve been doing analysis of oral drug product excipients and API for nitrosating agents and the laundry list of small non-API related nitrosamine impurities. We’ve been using high res UPLC/MS and GC/MS primarily. For excipient testing, we’ve been using primarily using IC for Nitrite content of excipients. I’ve been plugged into the Lhasa working group on Nitrite/Nitrate testing thought IQ.
I’ve been in the industry for almost 30 years both in analytical development and manufacturing tech services roles across R&D and Manufacturing.
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Hello. My Name is Figen Yilmaz. I am chemist and has over 25 years of experience in pharmaceutical industry. Currently I am working as consultant-trainer for GMP, GLP, GDP, V&V, CMO management, TT management, QRM, cost-reduction projects. I am a Board Member of ISPE Turkey Affiliate since May 2016 and currently I am approved ISPE trainer for GMP topics. We are providing nitrosamine risk assessment projects to Turkish companies and therefore I am trying to catch up every information about nitrosamines.
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Hi, I am Matteo Villain. I lead the CMC Development group at Bachem Americas. I’m part of the team that executes risk assessment for Nitrosamine contamination for Bachem’s peptidic APIs (DS).
My efforts are more related to identify risk of Nitrosamine formation during processes, not as much in the biological aspects of Genotoxic limits in case a nitrosamine is formed. But I’m here to learn more of the establishment of limits.
I’m a little disturbed of the new course of events. We started this emergency in 2018 with a well defined group of Nitrosamine contamination associated with reagents and degraded reagents, and now we are moving into the issue of the API itself as substrate for nitrosamine formation (propranolol and quinapril). And the issue seems to be affecting the most reputable Pharmaceutical companies.
So I think there is a lot to be done to understand the real source of the problem (strategically). I hope this forum can initiate a discussion around the root cause of this problem, and move from the tactical analysis of the individual issue to the higher level strategical solution of the underline root cause.
Matteo
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Hi, I am Venkatesan G I am working in JUBILANT GENERIC Pharmaceutical company in India , wherein I am QMS risk assessment team member. Being API 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 from the time being it got introduced due to Sartans. There were different approaches and understanding across pharma industry on Nitrosamines however things got evolved based on the guidelines introduced by USP & EMA which helped a lot however still it needs a lot clarity. I am happy to be part of the Nitrosamine exchanger.
Thanks & Regards,
Venkatesan G
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@VENKATESAN.G welcome to Nitrosamine Exchange… Can you share your thoughts on: What would you say has been most challenging things when dealing with Nitrosamines for you and your team? and how did you overcome that challenge?
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Hey everybody,
my name is Mandy and im Head of QA Compliance within an CDMO and therefore among a lot of other topics responsible for Nitrosamines with regards to additional customer service, as we do not have any products by our own and are therefore no MAH.
I´m biologics backgrounded and happy to find so much background in very great details on this exchange!
Thanks for implementing
Best regards
Mandy
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Hii Everyone…
Myself Jigar Shah having more than 13 years of experience in the field of Analytical development and Validation for OSD as well as Injectable projects. Currently i am leading dept of analytical in Baroque Pharmaceuticals Pvt Ltd, Gujarat, India.
We are working with various anti-diabetic agents and they may be with Nitrosamine. So, we have developed method for nitrosamine and also doing risk assessment for that in formulation and API also.
This group will give good opportunity for this kind of discussion.
Hoping for best…
Regards,
JIGAR SHAH
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Hi - My name is Srinu Kailash.Rudra working as a functional head regulatory affairs in Neuland Laboratories Limited, India and having 22 plus years of experience in the domain of regulatory affairs of API, prior to Neuland, I worked with Aurobindo API regulatory.
It is a great privilege to be part of this forum and give immense benefit to the industry to exchange lot of information on this volatile subject. Even I’m curious to understand why FDA is still not given guidance clarity on applying 18ng/day as an AI for unknown nitrosoamine impurities.
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Hello everyone, I am Nathanael Page, Principal Scientist in Analytical and Materials Science Solutions (AMS) within the Drug Development Solutions CRO at Fordham UK. I have been working with the team on nitrosamines since 2019, with a focus on the use of HRMS and QqQ for identity confirmation and the development of quantitative methods respectively. We are actively supporting the analysis of both API and non-API related nitrosamines in a range of medicines and healthcare products. It’s great to see a community formed around this ongoing issue and I look forward to collaborating with the community as this area evolves.
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Hi , I am Selvaraja Elumalai and associated with Ambiopharm – Global Peptide MFG company located in US/China , wherein I am heading QC and AD . Being a Peptide manufacturing organization, we ensure our DS/DP products should be free from Nitrosamine’s risk. We are extensively working on Nitrosamine’s risk assessment for DS and DP for many products. There were many guidelines introduced by USP & EMA & multiple workshops which helped a lot however still it needs more clarity on unclear area. Interested to be part of the community wherein can learn and share knowledge.
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Hi，我是中国一家原料药企业的研发QC，我一直努力于基因毒性杂质包括亚硝胺杂质的研究工作，确保产品质量安全是我的工作使命，我将会继续努力学习，让我们做得更好。
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