Hi, i am having 11 years of experience in formulation development. Presently i am involved in nitrosamine risk assessment. I like to get updated regularly with scientific & regulatory information about Nitrosamine topic.
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Hello,
Thank you for approving, I’m Monica Kosa, a computational chemistry expert, currently associated with Novartis, interested in nitrosamines evolution in the drug product.
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Nice to meet you all!
My name is Carolien, currently working as a toxicologist at Synthon BV in the Netherlands. I am trying to stay on top of the Nitrosamine topic, and look forward to following and joining the conversations in this Nitrosamines Exchange group!
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Hello all,
This is Sachin Goyal, working with pharmaceutical company in India as QA head.
Looking for best practices to be deployed to control and measure Nitrosamines.
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Greeting,
I am Diako Khodaei. A senior postdoc researcher at TU Dublin, Ireland. My project is focused on the detection of Nitrosamines in processed meat samples in order to develop Nitrite free products. Also, I will work on modeling the formation of nitrosamines in relation to different food processing and formulation to find a better understanding of nitrosamine formation in food. The other part of my project is to analyze MDAs and their interaction with NAs in processed meat. I am Food Scientist and new to the NAs world but hope to build connections here and improve my knowledge on this topic.
Regards
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Hello I am a contractor working for large pharma/medical device company that produces both kidney dialysis products and devices worldwide. Most test methods transfer to the US from other global sites including Germany and China. Currently performing test method validation at one of the US sites for the analysis of nitrosamine leachables in aqueous finished drug products (such as 0.9% sodium chloride injection and PD solutions by LCMSMS (APCI). The method includes SPE step for cleanup and to concentrate the samples. We are definitely having some problems with NDMA at the LOQ (lowest calibrator) and typically at 0.75- 1.0ng/mL depending on the drug matrix. It will be a challenging assay and look forward to reading more posts about nitrosamines and optimizing analytical test methods/validations. Thank you, Kate Evans PhD Longboard Scientific.
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Hi,
my name is Ricarda Leister and I am heading the R&D department for excipients at MEGGLE.
I have more than 20 years of experience in the pharmaceutical industry. Before joining MEGGLE I have been working for different big pharma companies mostly within Technical Operations (MS&T, Tech Transfer & Launch Management).
Regarding nitrosamine it is important for me to understand how we can support our customers best (e.g. reformulation support, IPEC Questionnaire).
In my opinion the analytical methods used to determine the nitrite in excipients or formulations are also an important topic, as the product matrix might impact the obtained results.
Looking forward to participating in the Nitrosamine Exchange community.
Yes, that is one of important topic, where group members can share the current analytical methods and trends.
Maybe in Analytical hub.
Naiffer, please advise.
Hi @vsnu999
we have a category in the community dedicated for any analytical related topic ‘Confirmatory Testing’
The Analytical hub is dedicated to methods that have been curated by USP from manufacturers, contract labs or even regulatory agencies. Any organization can donate their method for them to become application notes within the Analytical Hub.
Hi my name is Fatima Attoun from Jordan
I am expert in the analytical research in pharmaceutical companies with more than 14 years’ experience, certified in Lean management and lean six sigma.
Currently I am working as technical support in a consultation company called Al-mesned consulting center for pharma industry that interested to submit in Saudi Arabia.
I am interested to know more about the nitrosamine impurities in drug substance and drug product, to help me in my work in consultation specially after SFDA notified manufacturers to provide a risk assessment in the initial submission for the impurities in the active pharmaceutical substance (Section 3.2.S.3.2) and impurities in the final product (Section 3.2.P.5.5).
looking forward to learning and sharing knowledge in this community.
Best regards
Fatima
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I’m Dr. Dinkar B. Gagare, and I work in regulatory affairs for the Indian company INTAS Pharmaceuticals Limited. I like researching new topic related to chemistry and API. Honestly, I’m glad I joined the “Nitrosamines Exchange group” because here discussions are realistic, Scientific background and it is very useful for Pharma and our Society.
Thanks and Regards,
Dr. Dinkar B. Gagare
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My name is Kapil Vaja, and I work in regulatory affairs at M/s. Intas Pharmaceuticals Limited in India. I enjoy learning about new chemical and API topics. I’m delighted that I have joined the “Nitrosamines Exchange group” since the conversations are scientific, and are really beneficial to Pharma industry.
Good day to all! I’m Anandakrishnan, leading API regulatory. I am excited to be a part of this nitrosamines scientific exchange forum. Thank you for adding me to this group.
Hie myself Nikhil Gunnam presently working as method developer for Nitrosamines, NDSRI’s in all types of formulations including parentrals, opthalmics , oral disintegrating films ,Tablets , capsules etc. by LCMS/MS and GCMS/MS. I had vast experience of LCMS method development for NDSRI’S. Presently playing keyrole as a method developer for many clients. Happy to join Nitrosamine Exchange. Thanks for Inviting.
Hello,
I’m Gabriela Nascimento, scientific derector at Science Consult. I’m located in Campinas, SP Brazil. I’ve been working to nitrosamines consultance, carrying out risk assessment and assisting in analyzes using chromatography coupled with mass spectrometry. My company offered last saturday the course “Nitrosamines: organic chemistry and toxicology”, our objective is to help with regulatory and analytical solutions. I’m honored and excited to connect and be able to collaborating in the community!
Hello,
I’m Fred Meadows, Senior Technical Advisor, CMC & Product Supply Management with the Promoting the Quality of Medicines Plus (PQM+) program. PQM+ is a five-year (September 27,2019 - September 26, 2024) U.S. Agency for International Development (USAID)-funded cooperative agreement with USP. Our goal is to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). My specific job is to provide technical assistance to manufacturers in product development, GMP compliance and other areas to ensure access to quality, safe and effective products. Nitrosamines are important for all manufacturers that we support.
@fmeadows, welcome to our Nitrosamine Exchange community. I hope you find the information and knowledge insightful. Fantastic to welcome USP’s colleague from our PQM+ program.
@Gnascimento welcome to our Nitrosamine Exchange community. I hope you find the information and knowledge insightful. We have several ongoing discussions on the risk factors and risk assessment. Your expertise will be more than welcome by the community. Don’t shy away from actively participating in ongoing discussions.
Hi All,
Myself Sanjay surani, I am working in analytical development department in zydus life sciences ltd. I would like to really thank to nitosamine exchange group for making this group for sharing new update regarding nitrosamines.
Thanks for accepting my request for participating.
Hi, My name is Khairil Sabri. I am from Malaysia currently work in Malaysia GLC company. Work experience with Pharmaniaga, YSP and current working with Duopharma company . I worked at the Pharmaceutical industry more than 10 years from QC and R&D team and actively evaluated the presence of nitrosamines in drug products also drug substances. We are extensively working on Nitrosamines risk assessment and Outsourcing this Nitrosamine testing also Validation from the time being it got introduced due to Sartans, Metformin and now new for us for NDSRI. For more understanding across pharma industry on Nitrosamines however things got evolved based on the guidelines introduced by USP, EMA and Health Canada which helped a lot however still it needs a lot clarity. Our team also looking any CDMO partner that can support us especially for evolution of Nitrosamine and any impurities future. I am happy to be part of the community wherein can learn and share our knowledge/ experience. Thanks