Introduce yourself here!

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?

@Naiffer_Host Thanks for including me in these group and warm welcoming.

As per my experience with different Pharma industry main challenges for analytical side is expertise and regulatory framework specific for LOD and LOQ, confusion for what are the Nitrosamines need to analyse? Need to evaluate excipient, intermediate, solvents etc require or not, for Biopharmaceutical and fermentation base product require assessment or not.

Thease are few points where industry people have not clarity. Need to focus on such points and require education for that specifically regulatory side.

Thanks

Dr. Jaideep @Jaideep, welcome to Nitrosamine Exchange. Limits is a fascinating topic for the community discussion, specifically for the divergence on approaches from regulatory agencies when establishing permissible limits for specific Nitrosamines. Additionally, the bio-chemistry of Nitrosamines is quite complex, which allow the question: Are all Nitrosamine equally genotoxic?
Can you share some of those questions with our community so we can start additional discussions? I hope you find insightful our discussions here… Thx

Naiffer,

I found it difficult to figure out how to use your site. I would be glad to help if I could but as a contract packager the responsibility for this risk assessment would be with the owner/manufacturer of the products we package. I couldn’t figure out how to post my question about the Pfizer recall…

Dina

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@dinamaines Thanks. We have created a very short video explaining

  • How to search the community
  • How to reply to a discussion
  • How to post questions to the community

While risk assessment is the responsibility of the owner/manufacturer I’m sure you have been part of those risk assessment exercises, I believe that general insight and best practices are gold nuggets for the community.

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Hello @Naiffer_Host it is my pleasure to be a part of such a wonderful group I can ever think of. Surely I will be posting questions on regular basis. Regarding the question are all Nitrosamies (NAs) genotoxic: I would like to let you know that no…basics lie in the chemistry of the molecule…NH group…same also arises if we have a diazo group (N2Cl) too. Nitrogen forms covalent bonds with DNA or cellular mechanism structures and donates its electrons. That donation creates free radicals and it is troublesome. Since in toxicology, we know dose decides the toxicity. However, we have been able to only identify and quantify 75 NAs. Maybe many are there that are out of LOD or LOQ. But limitations with in-silico software are they treat all same. Now it is something under discussion from FDA and other individual regulators too that we need to change the concept of One size fits all. Since historical data with quantified NA have genotoxic data, all cant be. Moreover, no specific study has not been identified for all 7 or 8 NAs whose values have been established. So, I am still skeptical that all NAs cant be genotoxic. In turn, genotoxic will lead to carcinogenic too. So, technically need to be argued and established upon this hypothesis.

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Thank you for the invitation @Naiffer_Host. My name is Danita Broyles, and I am the Associate Director of Quality Assurance at Harmony Biosciences focusing in Analytical and Stability areas. Thank you so much for creating an information exchange on this very important topic. I am looking forward to sharing ideas and collaborating with the group concerning Nitrosamines.

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