@frigyes Welcome to Nitrosamine Exchange. We are currently having a specific discussion on that area triggered specifically by recent ANVISA’s Nitrosamine guidance publication. I invite you to visit #limits to post some of those burning questions. Welcome!
Hi everyone, its a pleasure to be connected with all stakeholders @ Nitrosamine Exchange, I am Ashay Mehta (Director, Doctors’ Analytical Laboratories). We are a contract testing laboratory based out of Navi Mumbai, India and successfully inspected by US FDA and approved by Health Canada. Our main role is to develop and validate test methods and batch analysis for Nitrosamines, GTI’s & Elemental Impurities for various pharmaceutical companies. Thank you for setting up this group which I am sure will be very helpful to the entire industry. Look forward to sharing and learning new updates and learnings.
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Thank you for your kind words Dr Naiffer. Apologies for the delay in reply. I would be glad to share my perspective as and when they are available and bring some value to the discussion.
Just to highlight that the Prequalification Team of Medicines (PQTm) in WHO is harmonized with other regulators (USFDA, EMA, EDQM) and collaborating with other regulators (e.g. Nitrosamines International Strategic Group). The PQTm continues to assess the information on nitrosamine impurities in APIs, following root-causes identified in EMA and US FDA guidance. This is the sole reason why we have not published a separate guideline as we believe the recommendations from USFDA and EMA are quite comprehensive.
You may note that the scope of therapeutic areas is limited in PQTm (such as HIV/AIDS, Malaria, Tuberculosis, Reproductive Health Products and so on). Within PQTm, nitrosamine risk has been confirmed in two APIs namely Rifapentine and Rifampicin.
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Thanks Naiffer, I got to know this group from one of the webinar. Looking forward to learn new knowledge in Nitrosamines from all the experts here.
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My self Mr. Paresh J Malaviya.
Hi, everyone, I am Dr Tabrez Shaikh, Sr. Manager - ARD at Indoco Research Centre, India. USP has created a good platform to share the knowledge related to a nitrosamine. A reason to join is that part of my work is related to analytical support and risk evaluation of genotoxic & nitrosamine impurities in DS & DP along with their QSAR predictions and toxicity evaluation. Happy to be part of this community.
Thanx
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Thankyou @Vimal for sharing the WHO perspective with the community, welcome to the group, we look forward to your Inputs in the discussions, it will immensely benefit the community.
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Hello everyone, my name is Sarah Kremers and I am a pharmacist from Leverkusen (Germany). I work at a company which, amongst others, analyzes various products for nitrosamines via GC-MSMS and LC-MSMS. I am happy to be part of this group and have some interesting conversations.
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Hii,
I am Shailesh, working as a Drug Safety Associate at APCER Life Sciences, India. Having been associated with safety of drugs, I see nitrosamine as one of the important aspects which needs to focus promptly. Morever, I studied Genotoxic impurities especially nitrosamine dimethyl amine (NDMA) present in Ranitidine containing products which has been elaborated in detail in my review article entitled Genotoxic Impurities In Ranitidine Containing Products: An overview.
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@CCHONG welcome to Nitrosamine Exchange, glad to know you decided to join the community after listening to our webinar. I hope you find useful the community and share with colleagues about this resource
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Hi, @PARESH Welcome to Nitrosamine Exchange. Can you share with us what’s has been your involvement and some of the challenges related to Nitrosamine in your work? Feel free to contribute to some of the ongoing discussions in the community
@tabrezs warm welcome to Nitrosamine Exchange. the core goal of our community is to share insights and knowledge related to Nitrosamine. Your work and experience will be a great contribution to the ongoing discussion on Q(SAR) and risk evaluation. Here are few posts that I am sure you can contribute:
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@SKremers Thanks and welcome to Nitrosamine Exchange. We have gathered a fantastic group of colleagues trying to overcome successfully the same set of challenges… A lot of information and resources here to share, and also several ongoing discussions that will welcome your contribution.
@Shailesh_b Welcome to Nitrosamine Exchange. Thanks for sharing your article with the community. Related to Ranitidine, we have an active discussion related to FDA studies and a recent investigator paper retraction. We will welcome your perspective and additional insight on this area. I know the community is wondering, Is it the end of Ranitidine in the market?
N-nitrosodimethylamine (NDMA) should be in acceptable limits in pharmaceutical products and should be monitored by the regulatory bodies. The NDMA level in ranitidine containing products was checked by the USFDA by conducting various tests. In addition, the USFDA has advised companies to voluntarily recall their ranitidine batches if it crosses the permissible limits (96 ng or 0.32 parts per million per day) of NDMA but on the other side, if the levels of NDMA lie in the acceptable limit then there is no need to recall the drug and it will be considered as safe.
Ranitidine.pdf (533.1 KB)
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Hi, I am Gunvat Yadav, Application Specialist-Mass Spectrometry in Spinco Biotech Pvt Ltd, India (Official Distributor of Shimadzu Analytical Instruments- HPLC and LCMS in India).
As application specialist I am involve in development of Triple Quade (TQ) LCMS/MS method for Nitrosamine for many drug products, drug substances (Sartan, Ranitidine, Metformin, DMF and NDMA in Metformin) and different solvents (as per regulatory requirement of low level of LOD and LOQ) and we developed many method to support Pharmaceutical customer in India. As I am closely work on Nitrosamine very happy to get more information specifically regulatory updates.
As per my experience during interaction with many pharmaceuticals industry I observed lack of awareness and confusion to address this issue. There were different approaches and understanding across pharma industry on Nitrosamines and need to require lots of clarity from regulatory agency.
Thanks for making me part of the community where I can learn and share my knowledge and experience.
Dina Maines, Director QA Nutra-Med Packaging Inc.
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Hi I am Dr. Jaideep Sarkar. I am a Board Certified Toxicologist associated with KHPL, as Global Toxicology Head. I take care of company queries and also issues raised by the QC team to deal with impurities qualification or setting limits (HBELs) for APIs, medical devices E&Ls, etc… It is a great platform indeed that I was searching to join and gain knowledge, as in addition to Nitrosamines, Nitro impurities are also getting noticed in Anti-Histamainic drugs. So, I guess will be great to learn and clear the cloud of doubts from you all experienced members.
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@Gunvat Welcome to Nitrosamine Exchange. I fully agree with you on the industry challenges about awareness. We hope this community can help fill some of those gaps. We have an incredible group of experts here that are willing to help and answers questions.
Outside, the analytical testing that we all know comes with its own set of challenges. In your experience with many manufacturers, what is missing? Is it a tool, is it regulatory framework, is it expertise?
@dinamaines, welcome to the Nitrosamine Exchange community - Your experience and feedback related to packaging will be welcome by our community members. We currently have a dedicated category within the community for packaging materials.
I hope you can help us guide some discussions related to challenges or not in the packaging when conducting Nitrosamine risk assessment? What has been your experience in this arena?