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Mr Nitin R Khaladkar, Head R&D – Rubber Stopper, Bharat Rubber Works
Speaker in this video:
Mr Nitin R Khaladkar, Head R&D – Rubber Stopper, Bharat Rubber Works
Topic:Nitrosamines impurities in pharmaceuticals – The rubber stopper connection
Key Highlights:
[1] Nitrosamines aren’t just an API issue. Rubber stoppers and packaging materials can also contribute to risk.
[2] Vulcanisation choices make a difference. Certain rubber accelerators can create amines that later form nitrosamines.
[3] Lamination is a strong mitigation tool. Laminated stoppers showed no detectable nitrosamines under tested conditions.
[4] Risk-based control is the way forward. Testing, extractables studies and ICH M7–aligned assessments help manage the risk without compromising patient access.
The post Mr Nitin R Khaladkar, Head R&D – Rubber Stopper, Bharat Rubber Works appeared first on Express Pharma.
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