Hello and welcome to the Nitrosamines Exchange Community.
Whether you’re new to the topic or you’ve been a here a while, we’re really happy to have you here and helping us build knowledge and best practices to carry out effective Nitrosamine risk assessments.
To get started, please introduce yourself. We’re keen to know who you are, what kind of work you’re doing, and how long you’ve been doing it for.
Feel free to invite friend and colleagues who will benefit from be part of our Nitrosamine Exchange community
@Nitesh@Himali.Uj@conudel@ASrinivasan Welcome to ‘Nitrosamine Exchange’. I was hoping you can introduce yourselves to the community, and share questions or contribute to the topics we have created.
All together will shape the structure, and discussions here in the community.
Hi, My name is Aloka Srinivasan. I am currently an independent consultant. I worked at FDA for ten years and at National Cancer Institute for seven years evaluating the presence of nitrosamines in drug candidates. I did my Ph.D. under Dr. R.N. Loeppky, one of the stalwarts of nitrosamine. My thesis was related to activation of beta oxidized nitrosamies. Who knew that all these years later, we will be talking about nitrosamines in drugs, an issue that was raised in 80s and 90s but not addressed. Happy to be part of this group.
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?
@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@firstname.lastname@example.org
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.