Excipients and impurities
At the Ahmedabad Pharma Summit 2025, Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries, delivered an informative session on the role of excipients in ensuring pharma
quality and regulatory compliance.
Dr Gothoskar began by addressing the growing global concern around impurities such as nitrosamines that can pose serious health risks. As regulatory authorities worldwide tighten scrutiny on nitrosamine levels in pharma products, he highlighted the urgent need for manufacturers to proactively mitigate these risks. He pointed out excipients, particularly in tablet formulations, play a significant role in either exacerbating or controlling impurity levels.
A key focus of the session was the importance of intelligent excipient selection. Dr Gothoskar stressed that excipient choice should not be driven merely by cost or availability. Instead, manufacturers must consider factors like chemical stability, reactivity, and purity to minimise the risk of nitrosamine formation. This approach ensures safer products, regulatory compliance, and enhanced patient trust.
The presentation placed special emphasis on Microcrystalline Cellulose (MCC), a critical excipient in tablet manufacturing. Dr Gothoskar described MCC as a highly versatile material valued for its excellent compressibility, binding properties, and contribution to tablet integrity and stability. He shared practical examples of how MCC improves manufacturing efficiency and enhances batch-to-batch consistency, leading to higher-quality pharma products.
He also highlighted Sigachi Industries’ contribution in supplying premium-grade MCC and other excipients, backed by strong technical expertise. He explained how Sigachi supports pharma manufacturers in optimising their formulations, meeting stringent regulatory standards, and addressing emerging challenges like nitrosamine contamination.
In his concluding remarks, Dr Gothoskar reiterated that in today’s regulatory environment, quality by design must extend to excipient selection. By partnering with excipient suppliers like Sigachi Industries, pharma companies can safeguard their products, protect patient safety, and build greater resilience in their operations.