Hi, I’m Makimura. I’ve already made posts on this nitrosamine community, but I forgot to introduce myself.
I have about 10years experience in method development and QC in generic medication manufacturer in Japan. I’m interested in control strategies of nitrosamines using LC/MS analysis. I appreciate this community and having great opportunity to exchange information and opinion
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Hi, my name is Dulce Chávez from Mexico City I recently joined the team at Lambda Cientifica, a laboratory dedicated to perform pharmacopoeial test to pharmaceutical industry and as a new proyect we are implementing nitrosamines analysis. So we are very interested in this topic.
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Hello, and thanks for establishing this open forum! I work as an independent consultant serving food, feed, fuel and pharma industries and most recently have collaborated with numerous new entrants into the fermentation-based manufacture of USP Alcohol, USP Dehydrated Alcohol, FCC Ethyl Alcohol, and grain neutral spirits. I look forward to expanding my knowledge about potential sources of risk in these respective manufacturing processes, about mitigation strategies where necessary, and about the continually evolving USP and FDA guidance on this important topic! I am looking forward to collaboration and am happy to contribute input to the discussion where appropriate. Best regards to all!
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Hi My name is Daljit Vudathala and I work with SGS Life Sciences. We are in the process of starting nitrosamine testing at our site. I would like to know more about decontamination procedure of work areas used for sample preparation for nitrosamine testing. Looking forward to hearing back some practical ideas.
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Hola @Dulce_Chavez, Bienvenida a Nitrosamine Exchange community. Con toda confianza navega la comunidad y agrega cualquier pregunta o comentario relacionado con tu trabajo. Saludos!
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@PowersNEI Welcome to Nitrosamine Exchange. You have a great opportunity to connect, discuss and connect with our experts in the community. As always your comments, questions and feedback are welcome!
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@Daljit Thanks for joining Nitrosamine Exchange. Those are really great areas of common interest in the community. Feel free to post your questions or raised them in one of the existing discussion connected to that topic.
Welcome!
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Hi, my name Do Thi Bich Thuan. I am analyst of National Institute of drug quality control of Vietnam. Now, I and our team are joining the USP and NIDQC nitrosamine impurities pilot project. I am very happy to participate in group to know more about Nitrosamine impurities.
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@ThuanDo Welcome to Nitrosamine Exchange. Feel free to navigate the community, contribute to any of the ongoing discussions and post any questions that you might have. It would be interesting to get to know a bit more about the regulatory landscape of Vietnam related to Nitrosamine Controls.
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Hi,
I am SHIRISH V ZALTE, Principal scientist- DQA at Lupin Research park Pune.
Heading process research -DQA and working for development, review and compliance including Nitrosamine and AZIDO as well.
Nitrosamine is to be controlled at the end product whereas the input materials , chemical industry, excipients are not abide OR not well updated yet on this front and needs to work up towards this as to overcome the end product safety issue.
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@Shirish warm welcome to Nitrosamine Exchange community. Feel free to navigate the community, share your insight and post questions in any of the categories. We have few question posted around AZIDO impurities, Can you help us answers some of those based on your expertise?
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Hi,
Mrre than happy to satisfy query if any.
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Hi am, Okeafor Anastecia Onyinye (BSc, MSc Industrial Chemistry), The Quality Control Manager, May & Baker Nigeria PLC, Lagos. We are currently purchasing nitrosamines to carry out the risk evaluation on one of our product containing metformin HCl in line with FDA acceptance limits.
In hope to get more information on the accurate and sensitive method for this evaluation, looking forward to know more from this wonderful tean.
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Hi I am Heajin Park.
I have been working for MFDS, South Korea since 2020, with a focus on quality assessment of chemical drug.
I am very pleased to join Nistrosamine Exchange and eager to communicate with you all.
Thanks!
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Hello, I’m Madeleine Joel, working as a Toxicologist at Preclinical Science - Föll, Mecklenburg & Partner GmbH, a drug development consulting service in Germany. We have been supporting companies in the field of nitrosamines for several years (e.g. RA, (Q)SAR etc.).
This platform is really an enrichment and I’m very happy that I can ask specific questions to a broad audience of experts here, thank you. Does anyone have experience with the content of the next two questions and would like to share this experience?
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In general, the nitrosamine evaluation (step 1: risk evaluation, step 2: risk assessment/confirmatory testing & step 3: risk mitigation measures) is required for all medicinal marketed products for human use. However, so far I haven’t been able to find any official document that deals how to handle nitrosamine evaluations for clinical trial materials; hereunder individual requirements for each clinical phases.
Do you know whether/when nitrosamine evaluations are to be carried out prior to drug product being marketed - and to what level (step 1, 2 or 3) at which clinical stage? (if so, references would be nice to have at hand) -
Have you come across nitrosamine evaluations being carried out on peptides made by a standard (FMoc-based) solid state synthesis? (references to such cases would be nice to know of).
Thank you very much for sharing your experiences!
I would also like to refer to a helpful question session of the AAPS Community’s initiative "Ask Me Anything Nitrosamine Risk Assessments” session with four experts on Monday, September 12, from 10:00 am–11:00 am ET. They will explain how to set up and execute a robust nitrosamine risk assessment, how to identify sources of potential risk, and what tools are available to help with this process. They say that this is a chance to ask anything. Here our client will address these two questions again.
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Hi everyone, I’m Sandeep Kumar Bind and I’m a scientist in analytical development at Zydus Life Science (PTC). My current focus is impurity profiling and nitrosamine assessment of drug products and drug substances. I’m honored to be here. This nitrosamines exchange (knowledge exchange) is a significant learning platform and an opportunity for all of us to explore nitrosamine assessment as well as risk evaluation in DP and DS.
I’m excited for learning and share of knowledge with you all to challenge of nitrosamine evaluation in DP and DS.
Thank you !
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Hello everyone, My name is Santosh Kumar. I am currently working (Sr. Researcher ) Analytical Department in China. I’m very glad to join this experts forum and also a great platform to learn & sharing the knowledge regarding nitrosamine related topics.
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Hi, I am Ravindra Palkar, Ph. D., associated with D. K. Pharmachem as Technical Director. Our prime aim is to ensure that our API has no risk of Nitrosamines. Initial risk assessment keeping severity of harm, Detectability of failure and probability of occurrence, then evaluation and mitigation of nitrosamines is a big challenge. Thanks for creating this forum, nice to be part of this group and looking forward to have fruitful interaction with you all.
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Hi !!! This is Mayur Desai from Alembic Research Centre, India working in Analytical Development of Drug Products.
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Hi, my name is Dr. Cristina-Ioana Nicolaie, and I’m working in the RD department at Sindan Pharma, a Teva pharmaceuticals company. I work on Nitrosamines risk assessment of oncologic drugs and use FDA&EMA guidelines as references, however I think that more clarity is needed and maybe a global international regulation would be necessary. Thank you so much for accepting me in Nitrosamines exchange community!
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