Happy 2025, Nitrosamines Exchange Community & Welcome member #5000

About Nitrosamines Exchange
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:tada: Happy 2025, Nitrosamines Exchange Community! :tada:
@trust_user_d @trust_user_c @trust_user_a @trust_user_b

Another year, another step closer to mitigating these impurities in your medicines! As we dive into 2025, let’s take a moment to celebrate YOU, the incredible scientists, researchers, and professionals who make the Nitrosamines Exchange the thriving knowledge hub it is today. Not less critical a BIG milestone for our community by reaching member #5,000

:hammer_and_wrench: 2024: A Year of Impact and Evolution
Here’s what we achieved together last year:
:white_check_mark: Community Growth: We welcomed hundreds of new members, expanding to over 5,000 active participants from 80+ countries—all united by the fight against nitrosamine impurities.
:white_check_mark: FDA Recognition: The Exchange continued to shape the conversation, with notable mentions at global regulatory meetings, including the FDA GDUFA workshop.
:white_check_mark: Top 5 Posts in 2024:
:one: The deep dive into nitroso amlodipine synthesis challenges sparked incredible dialogue.
:two: Practical solutions for analytical testing under tight timelines.
:three: Updates on regulatory deadlines and compliance tips.
:four: The groundbreaking conversation on AI in nitrosamine impurity detection.
:five: Shared success stories in mitigation strategies from the community.

:bulb: Looking Ahead: What’s Your 2025 Nitrosamines Resolution?
As we tackle this year’s challenges, what are you committing to?

  • Collaborating more?
  • Mastering new testing methods?
  • Advocating for transparency and knowledge sharing?

Drop your resolutions in the comments below!

:mag: What’s on the Horizon for the Nitrosamines Exchange?
Here’s what we’re cooking up for 2025:
:rocket: Risk Assessment Evaluation Crowdsourcing Initiative: Share and refine best practices together.
:mortar_board: Education Sessions with Experts: Practical learning opportunities from global leaders.
:speech_balloon: Nitrosamines Conversations: New discussion threads focused on emerging trends.
:globe_with_meridians: Community Expansion: With your help, we’ll connect with even more scientists worldwide.
:bar_chart: Data & Knowledge Sharing: Let’s break silos and foster innovation through open dialogue.
:robot: AI Tools for Insights: Exploring how AI can support testing, risk assessments, and more.
:microscope: Analytical Hub Expansion: More tools, resources, and methods to streamline your work.

And this is just the beginning. Together, we’ll make 2025 a year of breakthroughs!

:confetti_ball: Here’s to a happy, impactful, and solution-driven 2025. Thank you for being the heart of this community.

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I am taking the liberty of echo some of the comments from Dr. Nudelman and Dr. Teasdale on their 2025…

Dr. Raphael Nudelman

Naiffer Romero My wish for 2025 is that all decisions and recommendations made for nitrosamines will be SCIENTIFICALLY based and not rely on less scientifically-based methodologies such as ALARP or batch analyses. Although some people believe that nitrosamines are magical creatures, I believe that they are muggles that behave as expected for a chemically reactive functional group that it is. I want transparency and I wish that health authorities would provide good scientific explanations to back their recommendations. Enough with the surprises. Let’s hope for a prosperous and productive nitrosamine year.

Dr. Andrew Teasdale

I would echo many of the comments already made by Raphy., in particular the concept of ALARP. How do you ever define this ? It might be argued that even if established it is a moving target. I.e., is something that you need to continuously review?

For a common generic would the introduction of a scavenger in one suppliers formulation for a product mandate others to do exactly the same? Surely there’s a risk that some products then become commercially non viable? We know from price gauging that having a single supplier or limited suppliers can have profound consequences.

My other concerns relate to other Nitroso species, in particular the possible use of species such as MNU as a surrogate to establish an AI. To my mind MNU is no more appropriate to use for such purposes as is NDEA/NDMA is for complex NDSRIs

@Maita

Naiffer Romero I’m seeking the implementation of best practices in nitrosamines management throughout Latin America to ensure continued access to safe and effective drugs in our region. Addressing the challenges posed by nitrosamine impurities is crucial for maintaining the safety and quality of pharmaceutical products. By adopting harmonized regulatory frameworks, conducting comprehensive risk assessments, and enhancing analytical capabilities, we can proactively minimize the risks associated with nitrosamines. Collaboration among regulatory agencies, manufacturers, and academic institutions is essential to achieving this goal. Through collective efforts, Latin America can establish a robust system that ensures compliance with global standards while protecting public health and maintaining confidence in the pharmaceutical supply chain.

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