The pharmaceutical industry faces ongoing challenges in managing the presence of potentially harmful nitrosamine impurities in drug products. At NINGBO INNO PHARMCHEM CO.,LTD., we are committed to providing solutions that enhance drug safety and quality. One such critical solution involves the careful selection of excipients, particularly Microcrystalline Cellulose (MCC), to minimize the risk of nitrosamine formation.

Nitrosamines can form when vulnerable amines react with nitrites, which are naturally occurring substances that can be present in various raw materials, including some excipients. Research has indicated that MCC sourced from different suppliers can vary in its nitrite content. Recognizing this, NINGBO INNO PHARMCHEM CO.,LTD. offers high-quality, low nitrite MCC grades. These specialized MCC products are designed to significantly reduce the potential for nitrosamine generation within pharmaceutical formulations.

By utilizing low nitrite MCC, pharmaceutical manufacturers can implement a proactive strategy for nitrosamine risk assessment and control. Studies have demonstrated that employing such excipients can lead to substantial reductions in nitrosamine levels compared to products made with excipients containing average nitrite levels. This is a crucial step in ensuring drug product safety and compliance with stringent regulatory standards. NINGBO INNO PHARMCHEM CO.,LTD. ensures that our low nitrite MCC is manufactured to the highest standards, providing a reliable component for building safer, more effective medications. Partner with us to secure your supply chain with excipients that contribute to the overall safety profile of your pharmaceutical products.