Managing nitrosamine impurities is a major challenge in the industry as nitrosamines can form during manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities.
Highlighting this issue in a presentation, Santosh Kakad, AGM – Sales and Marketing, Nitika Pharmaceutical Specialities discussed the impact of excipient selection on nitrosamine formation in drug products.
Nitrosamine formation is highly influenced by nitrite levels in excipients like microcrystalline cellulose (MCC), lactose, and superdisintegrants. High nitrite levels can increase nitrosamine formation by up to 151 per cent. Therefore, changing the supplier of MCC or such critical excipients can reduce nitrosamine levels by up to 89 per cent.
Kakad emphasised the importance of selecting low-nitrite excipients to reduce the risk of nitrosamine formation and improve product safety. He also informed that Nitika offers products like MCC, magnesium stearate, and sodium stearyl fumarate with low nitrite levels.
These excipients are part of a strategy to mitigate nitrosamine risk and enhance patient safety. This approach can be vital for high-risk formulations and aligns with regulatory guidelines to validate the safety and efficacy of pharma products.