Introduction to the Nitrosamine Risk Assessment Tool

MEGGLE has launched the online tool “Nitrosamine Risk Assessment Calculator” to support nitrosamine risk assessment during pharmaceutical formulation development.

■ Key features – two complementary modules
・Basic Calculator ：It‘s designed for quick initial screening. The user enters the API name, tablet strength and size, and selects the manufacturing process type and amine type — both of which determine the expected nitrosamine conversion rate. The tool automatically retrieves the relevant acceptable intake (AI) limit from the official EMA list and calculates the maximum nitrite level that excipients are allowed to contribute while staying within the accepted safety threshold (10% of the AI). This enables a fast, conservative first assessment of whether excipient nitrite levels are a potential concern — without requiring detailed formulation data.

・Extended Calculator：It‘s is used when a more detailed evaluation is needed. Building on the Basic Calculator inputs, the user additionally enters the full formulation composition — individual excipients, their proportions, and their nitrite levels. The tool calculates the amount of nitrosamine potentially formed and compares this against the accepted safety threshold. Results are presented as a transparent summary of API and excipient contributions and the applied conversion rate. Depending on the outcome, targeted risk mitigation measures are proposed, such as the use of low-nitrite excipients, process optimization, addition of scavengers, or packaging improvements

Our calculator is based on the updated EMA Appendix 1 (March 2026), enabling structured risk evaluation and formulation optimization in line with regulatory requirements.

▼Discover the Nitrosamine Risk Assessment Calculator at
https://www.meggle-excipients.com/nitrosamine-risk-assessment-calculator

■Learn more – request our whitepaper:
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