Hello, I’m Andrew Feilden the European E&L Strategic Director at Hall analytical. I am an analytical chemist by training. I have been involved for a number of years on Nitrosamines, initially those that come from typically nitrile rubber but then more recently with those from drug substance and drug product.
Greetings. I’m Susan Felter, working in the Corporate Human Safety division at Procter & Gamble. I am responsible for the company’s cancer risk assessments (globally) and also have a very active role in advancing the scientific basis supporting the Threshold of Toxicological Concern (TTC). Consideration of how the extensive data on nitrosamines can be used to establish a class-specific TTC and/or how potency bins for nitrosamines can be established is also an area of interest and research.
Hello, I am Jie Liu in USP Scientific Affairs team based in Shanghai, China. I am excited to be part of this community. As you know, China was the epicenter of nitrosamine incident, many stakeholders were affected and are still struggling. This platform will be very valuable for knowledge exchange and will beneficial for stakeholders. Thanks.
Hi, I am Dr.Anurag Trivedi. I am working with Lupin Ltd in India as Vice president API Analytical, we have started working on Nitrosamine Impurities since issues were observed in Sartan products.
We are working on various approaches to assess the risk in API as well drug products produced by Lupin. The biggest challenge we face during assessment is gathering proper information for raw materials / solvents /water quality etc. Analytical method development is also quite challenging since we need to use high end hyphenated techniques due to requirement of low level of LOD and LOQ.
Thanks for creating this forum and I am more than glad to be able to contribute to it. It will be of great help to all in the industry.
@andrew_feilden welcome to our community. Please feel free to check the categories we have created as the framework of discussions. Any feedback is welcome.
I was wondering if you can share with us what you might consider the most challenging part of Nitrosamine Assessment when it comes to E&L. I believe this is an area that there is still lot to be research.
A post was split to a new topic: LTL or not LTL that’s the question?
@Anuragtrivedi Thanks and welcome to the community. I am sure our community would have many topics to discuss related to your experience on Sartan. I would start by asking to share with us what would is the biggest lesson you learn from the first experience with Sartan products?
Hello Community… fantastic week welcoming new member to our community. I would like to introduce @Ward from Nelson Labs @SusanFelter (Who already introduce herself, thank Susan) @jbercu from Gilead, @Anuragtrivedi from Lupin… to all Welcome!
I was hoping you can introduce yourselves to the community, and share questions or contribute to the topics we have created.
I’m Amanda Guiraldelli, scientific affairs manager at USP, and I’m located in São Paulo Brazil. I’ve been working on nitrosamines analysis in pharmaceuticals using chromatography coupled with mass spectrometry and I’m always seeking to learn more about the different sources of nitrosamines and topics related to nitrosamines risk assessment. Happy to be part of this community where I’m quite sure I’ll find rich discussions around nitrosamines.
Hi, My name is BM Rao, Ph.D. currently working at Dr. Reddy’s, Hyderabad, India (since Sep, 2015) as Head - EM QA, CQC & ASAT. I am working along with my colleagues from Analytical Science & Technology (ASAT) on the methods development for nitrosamines (both APIs & DPs) followed by method validation and confirmatory testing. Very happy to be part of this group. thank you for sharing the invite.
I am Dr. Sourish Karmakar, AGM QA. I have been managing In process QA for past 2 years. Previously, I worked in roles of both R&D and Manufacturing of Biologics (Recombinant Protein).
This is Dr Adwait Deo from Ajanta Pharma. we have been working on nitrosamine risk assessment and related method development. Nice to be part of this group and looking forward to fruitful interaction with you all.
Thanks! I lead the group responsible at Merck & Co for structural characterization and mechanism elucidation for degradation products, kinetics of formation, and the strategy for Nitrosamine risk assessment and control in drug products. Excited to be here!
A post was split to a new topic: Risk Assessment checklist, is that enough?
Hello Dr. Nitesh, how are you? Thanks for sharing your valuable insights.
For your question related to ONCO products, you can refer to EMA/369136/2020 ‘Committee for Medicinal Products for Human Use (CHMP)’ published on 25 June 2020 (Recommendations section: point no. 6), which is as follows:
“Exceptions to sections 3. and 4. include some products falling outside the scope of the ICH
M7(R1) guideline, i.e. certain active substances and finished products intended for advanced
cancer indications or when the active substance is itself genotoxic. For finished products
intended only for advanced cancer, N-nitrosamine impurities should be controlled according to ICH Q3 A(R2) and ICH Q3B(R2), as specified in the Q&A document to ICH S9. When the active substance itself is genotoxic at therapeutic concentrations, N-nitrosamine impurities could be controlled at limits for non-mutagenic impurities according to ICH M7(R1)”.
nitrosamines-emea-h-a53-1490-assessment-report_en.pdf (1.3 MB)
You can also refer to ‘EMA/409815/2020 Rev.1’ Qand A published on 29 January 2021.
2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf (499.7 KB)
How do you consider this approach?
Hello Dr. Archana,
Welcome to Nitrosamine Exchange community. Glad to connect with you through this forum. Appreciate your insights and the risk assessment resources shared by you are of great help to the community members.
Do you follow or prefer any specific tool to conduct risk assessment in APIs and DPs?
Hello Dr. Adwait,
Glad to connect with you and welcome to tthe community of experts.
@leonardo.allain Welcome to the community. Thanks for sharing your experience related to Nitrosamine. I recalled the wonderful presentation you deliver as part of USP Brazil workshop serie.
Can I ask you to share with our community some of the tools or resources (beside M7) that in your experience are a go-to when defining or developing Nitrosamine Strategy?
@AmandaGuiraldelli @Mrunal Welcome to ‘Nitrosamine Exchange’, We have some great community members whose work is focused on analytical work. One of the key pillar on Nitrosamine overall strategy. looking forward some great discussions
@drbmrao welcome to the community. I am sure the community will welcome all your experience on dealing with Nitrosamine Impurties. Please feel free to browse some of our discussions and share some of your experiences. Thx