Dr Ravleen Singh Khurana, MD, Nitika Pharmaceutical Specialities

Speaker in this video:
Dr Ravleen Singh Khurana, MD, Nitika Pharmaceutical Specialities

Topic: Role of low nitrite excipients in nitrosamines risk mitigation

Key Highlights:
[1] Excipients may contribute to the formation of Nitrosamines through precursor substances present in the excipient (e.g. nitrites, amines). Nitrite impurities are found in most of the commonly used excipients, at least in traces.

[2] Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry.

[3] Incorporate nitrosamine risk mitigation during excipient development. Control reactive species (e.g., nitrites, amines) through robust design.