As regulatory bodies sharpen their focus on nitrosamine formation, pharmaceutical companies are under growing pressure to control all contributing factors—including nitrites in excipients.
At DFE Pharma, we’ve developed a free Nitrosamine Risk Calculator—a simple, science-backed tool that helps you:
· Estimate potential nitrosamine formation in your formulation
· Assess the impact of excipient selection and nitrite levels
· Make informed formulation decisions early in development lifecycle to stay compliant.
In fact, changing just one excipient (MCC or lactose) can reduce theoretical nitrosamine formation by up to -84 and -80% in model formulations. Changing superdisintegrants can decrease nitrosamine formation by -36%.
Try the Nitrosamine Risk Calculator now: Use the Tool
It’s fast, easy to use, and requires no installation or registration.
For questions or guidance on how to interpret the results, our team of formulation experts is here to support you. Contact us for expert advice on choosing the right excipients for safer, compliant formulations.