@pstlaur Welcome to Nitrosamine Exchange; I hope you find the community insightful and educational. Please do not hesitate to post questions in the community as you learn more about this great topic!
Hello Nitrosamine Group,
It was very helpful for me to attend a webinar where a professor from USP ( University of Sao Paulo) : Dr Ernani Pinto ( Head of Toxicology Department) exposed clearly the analytical methodology they developed for nitrosamine detection and quantitation.
In simple words he said that , since nitrosamines has no real chromophore group rendering either Visible or UV absorption it could be difficult to determine with HPLC UV detector , but , with LC MS and QqQ ( an spectra of MS and/or MS2 and /or MSn could be obtained and quantifyied)
Also take into account that ANVISA Guide 50/2021 version 1 clearly states :
6 7. TESTES CONFIRMATÓRIOS (ETAPA 2)
377
378 a) Método analítico
379
380 Assim como para outras impurezas, a avaliação laboratorial da presença de nitrosaminas requer
381 a aplicação de procedimentos analíticos sensíveis e seletivos, sendo muitas vezes necessária a associação de
382 diferentes técnicas analíticas como de separação cromatográfica associadas à identificação e quantificação por
383 espectrometria de massas, por exemplo.
384 Embora a Farmacopeia Brasileira ainda não disponha de método de análise de nitrosaminas,
385 vários procedimentos têm sido desenvolvidos e tornados públicos inclusive por autoridades regulatórias como
386 a Agência Europeia de Medicamentos – EMA (EDQM 2020), Agência Americana de Medicamentos e Alimentos
387 - FDA (FDA 2019) e Agência Canadense de Medicamentos - Health Canada (Health Canada 2019).
Resuming: ANVISA accepts MS as analytical technology and , since Brazilian Pharmacopoeia doesn´t own a methodology for nitrosamine quantification, they offer a broad list of codex references that can be - temporarily - used in regulatory issues .
Hope this could be of use !!!
Thanks
Claudio Cerati
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I’m Lucas Maciel, currently in charge of developing analytical methodologies to quantify nitrosamines in API and drug products by LC-MS. It is a hot topic and all the experts are involved. Thanks @Naiffer_Host for the invitation to be part of this community e congrats on the initiative!
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Hi, I’m Ruth Lee from USP APAC team. I’m the Associate Director, Govt Policy and Regulatory Affairs under the Global External Affairs team. Mhy apologies that my ID is a number 64424773…no sure how to change my ID…nevertheless, i’m glad to be part of the community as i have a keen interest in pursuing a nitrosamine impurity pilot project with regulatory agencies via post marketing surveillance activities to ensure quality of medicines in the supply chain. Let me know if anyone is interested to work on this project and i’ll be happy to connect with you.
My contact is ruth.lee@usp.org and mobile is +65 88266797.
For your info, i’m currently in the process of working out the pilot project scope etc with one of the national laboratories in ASEAN.
Hope to hear from the experts in this community.
rgds
Ruth
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Hello,
I’m Monika Deptula and I am working for Polpharma Biologics S.A as the MS&T expert. Nitrosamine risk assessment for biologics is one of the topic where I am engaged. I’m interested your expirience in this field, therefore I’m happy to be part of the community.
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Hi everyone!
Good morning.
It is my pleasure to be part of this team. By the way, my name is Dr.Vishnu Marisetti working for ScieGen Pharm Inc, New york. I am heading the Analytical R&D department in our firm.
The recent trends in nitrosoamines in various drug products and drug substances are alarming for the requirements of high sensitive analytical methods and stringent controls in drug manufacturing processes. Moreover, understanding of various sources of nitrosoamines either process or degradation impurities requires insightful understanding of process, reactivity, degradation pathways, and possible cross contamination, etc. Recent FDA guidance and USP<1469> laid some foundation and developed common understanding across the industry and regulators. Risk assessment approaches are the best tools yet for the assessment.
However, still more to improve on the current topic, hope this kind platforms would be useful to discuss, and work towards solutions on existing issues in the current topic.
Thank you Naiffer and all other experts.
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Hi,
I am Sanjay associated with Lupin limited. Involved in the impurity profiling, risk assessment of chemicals and setting in-house HBELs. Thanks for making me a part of this group!
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Greetings, I’m Vadi Bhat, Biopharma market specialist and BDM at Agilent, India. I am an analytical biochemist and LC-MS expert by training. I have been working on omics and biopharmaceuticals for number of years. My recent focus is on product and process related impurities in biologics, including nitrosamines in biologics. Happy to be part of this group.
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Hi.
I´m Ferran Sánchez, Market Development Manager for EMEAI at SCIEX MASS SPECTROMETRY.
We have been on top of the Nitrosamine analysis since the first recall occurred back in 2018. Once the analytical needs are clear for us as a company in what concerns to the characterization and quantification of the regulated compounds, I´m very interested to increase my knowledge on the most recent trends related to all possible Nitrosamine, but also to understand the procedence and the formation of the different nitrosamine during all the manufacturing process with the aim to create new solutions than can help our Customers to be ready for any eventuality may occur.
Thank you Naiffer and all other experts in the group for the brilliant conversations and participation.
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Hello All,
I am Suman Chakravarti, working in a company called MultiCASE Inc. My research interest are QSAR, cheminformatics and development of novel algorithms for computational approaches in predictive toxicology. Very happy to join this forum.
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Dear Naiffer, dear all,
as a short introduction, I am happy if I am able to bring in the experience from a leading position of the global nitrosamine taskforce of my company (Merck KGaA, Darmstadt, Germany, Life Science business sector), and the IPEC Europe, APIC and BioPhorum nitrosamine taskforces, where I am active member or TF lead.
Best regards,
Ulrich
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A special welcome to our new members from the recent USP India Workshop on Excipient Impurities @Chinkal4391 @Wuping @Abhishek @Satyajit @archanakukunoor @aniluy81 @Hemant @HimikaChoksi @Leninkumar @manish @shashi1950 @Ulrich
I was hoping you can introduce yourselves to the community, and share some of your work and activities related to Nitrosamine Impurities (Thanks Ulrich for taking the lead!).
Please feel free to navigate our community categories/discussions, add your perspective/comments to any ongoing discussions or simply start a new one with your specific topic of interest or questions to the community.
@Ulrich welcome to Nitrosamine Exchange, I am looking forward to your contributions in some of the discussions, especially those related to Excipients. Judging from our recent USP Workshop discussion on the Excipient track, we still have work in front of us…
@chakravarti_suman Thanks for joining Nitrosamine Exchange. Fascinating work you presented at PhRMA recently. I wondered if you could help us start some discussions for in-silico based models for potency assessment of Nitrosamines. Thx
@vadibhat71 welcome to Nitrosamine Exchange … we have a dedicated category in the community to Nitrosamines in Biologics. Please feel free to start a new discussion or add to an existing one about your experience and perspective on the role of Nitrosamines in biologics. Thx
@sanjaybokan Welcome to Nitrosamine Exchange. In your work realted to profiling and risk assessment. What’s your reflection on the most challenging part of risk assessment? What tools have been the most useful when deploying your company risk assessment? Thx
@vsnu999 Thanks for accepting the invitation and welcome to our Nitrosamine Exchange knowledge community.
…“Still more to improve”, would you help us prompt some questions in those specifics that you find most challenging? Thx
@Monika-Dep Thanks and Welcome to Nitrosamine Exchange. Nitrosamine and Biologics is an area of the community where we would like to learn about from your experience and perspectives. Please share some of your reflections on the impact extend of Nitrosamine in Biologics. BTW, we have a dedicated category for Biologics within the community. Thx
Hi all, I was wondering if anybody has tried building predictive models, QSAR or otherwise, for predicting nitrosamine’s carcinogenic potency. If so, please share your experience and in that way we can have a good discussion!
Hi
I am Kevin Swiss, Principal at CMCGMP LLC and Vice President at Synerg Biopharma, in the distant past I was a CMC Reviewer in Pulmonary and Allergy Drug Products under Guirag Poochikian and Steve Koepke. While there 21 years ago, I was in a working group of two (with Robin Huff) in the FDA regarding Nitrosamines. Back then through early work by Steve Koepke we knew Nitrosamines were carcinogenic and were found in o-rings in MDIs but that was about it due to the limitations of ICH Q3A/B. In our working committee we established a reasonable list of structure alerts including Nitrosamines which eventually became ICH M7, Derek, Leadscope etc. Subsequently I have worked as a consultant at various companies helping many to overcome issues in CMC/CMC Reg/QA as needed.
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