Dr Vivek Jha, Head – R&D, Cilicant & Mr Dhairy Sharma, Manager – Business Development (Healthcare Division), Cilicant

Speakers in this video:
Dr Vivek Jha, Head – R&D, Cilicant & Mr Dhairy Sharma, Manager – Business Development (Healthcare Division), Cilicant

Topic: Can Frexil minimize nitrosamine risk? Let’s discuss!

Key Highlights:
[1] Nitrosamine formation is driven by multiple factors across the product lifecycle, including API chemistry, nitrite exposure, moisture, storage conditions, and manufacturing processes, making proactive risk management essential.

[2] A science-based, risk assessment framework is critical to identify and prioritise high-risk areas, with factors such as nitrite levels, pH, moisture, and process conditions having the greatest impact on NDSRI/NDMA formation.

[3] Effective mitigation requires end-to-end control strategies, including raw material qualification, process optimisation, environmental controls, packaging considerations, and analytical monitoring to ensure patient safety and regulatory compliance.