In this video:
Ravleen Singh Khurana, MD, Nitika Pharmaceuticals Specialties
Topic: Future trends in excipients with low nitrite
Key Highlights:
[1] Nitrosamines form from nitrites reacting with amine-containing APIs or impurities. The levels of nitrites in excipients influence nitrosamine formation. High nitrite levels increase formation by up to 151%
[2] Managing nitrosamine impurities is a major challenge in the industry. Changing the MCC supplier can significantly impact nitrosamine levels.
[3] Variations in excipients like MCC, lactose, and superdisintegrants affect nitrosamine formation in formulations. Lhasa Limited’s database provides validated data on nitrite levels in excipients to aid in risk assessment.
[4] Products offered by Nitika i.e. Microcrystalline Cellulose (MCC) and Magnesium Stearate and Sodium Stearyl Fumarate provide trend data on nitrite and nitrate levels