Managing nitrosamines that form during manufacturing and storage, due to reactions between nitrites and amine-containing APIs or impurities, remains a significant challenge for the pharmaceutical industry.
At the FDD Conclave 2025, Dr Ravleen Singh Khurana, MD, Nitika Pharmaceutical Specialities, addressed this concern by highlighting how the choice of excipients can influence nitrosamine formation in drug products. Nitrosamine formation is highly influenced by nitrite levels in excipients like microcrystalline cellulose (MCC), lactose, and superdisintegrants. Average nitrite content and batch-to-batch variance differ among excipient types.
Therefore, consistency of low nitrite excipients is key. High nitrite levels can increase nitrosamine formation by up to 151 per cent. While changing the supplier of MCC or such critical excipients can reduce risk by ~10x. Khurana emphasised the importance of selecting low-nitrite excipients to reduce the risk of nitrosamine formation and improve product safety.
He also highlighted the offerings by Nitika, such as 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.