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.