Within Lhasa and within the working group, we have been actively engaged in nitrosamine research for almost 18 months at time of writing, resulting in a number of papers on the issue already, with many more to come. If editing posts is permitted, I will attempt to update this in future, otherwise will make additional posts; however, for now please look at the following:
Hi, I am Dr.Nitesh Kanyawar. I am associated with Cipla Ltd – Global Pharmaceutical company in India , wherein I am heading 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 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 community wherein can learn and share our knowledge/ experience. Thanks
Thanks for joining us, I’m glad we can have you as one of our first members. In your experience helping organizations dealing with Nitrosamine Impurities, Are there any particular issue or challenge related to Nitrosamine that you would like to discuss with the community members? We’re keen to help!
You’re exactly the kind of people we want to have in this community, thanks for becoming one of our founding members.
When I first introduce our community to you and @Himali.Uj you both shared with me interesting challenges and the diversity of approaches taken by industry to address Nitrosamine Risk Assessment. Do you feel there is more alignment in the industry now that we first learn about Nitrosamine in Valsartan back in 2018?
If you have a second, can you please response to one or two of the outstanding questions we have at the momento to get things started?
Great to have you here. The industry working group sounds really interesting. I would definitely be interested in inviting them to join our community too if you think it might be a good fit.
Feel free to create post and drop any paper or relevant information into the research category we have here. I know other members will find them useful.
@vcoscia@fernandaw@andresaopedro Welcome to ‘Nitrosamine Exchange’. I was hoping you can introduce yourselves to the community, and share some of your experience related to Nitrosamine.
All together will shape the structure, and discussions here in the community.
@leonardo.allain@AndyTeasdale Welcome to ‘Nitrosamine Exchange’. I was hoping you can introduce yourselves to the community, share some questions or contribute to the topics we have created to get our discussion started.
Our little community is starting to take shape with some amazing founders. All together will shape the structure, and discussions here in the community.
Hello, I am Mrunal Jaywant, Senior Director - R&D at USP India. I have been closely working with our stakeholders on Nitrosamine topic to understand their needs and expectations from USP. I am excited to be part of this community and learn from experts. This platform would facilitate knowledge sharing and exchange of ideas, which would help us gain valuable insights and develop appropriate standards for our stakeholders. Thank you.
Dear community members,
I would like to welcome few new members this week @kenyom01@John240872@andrew_feilden@riskscience@frankliu@leonardo.allain
May I ask to introduce yourself to the group and share some of your experience with Nitrosamine. As a reminder you are now part of our founding community and would love to learn some of your perspective in the discussion questions we have posted throughout.
Kudos on becoming founding member of the community
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.
@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.
Hi,
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.
