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NDSRI Impurity Limits Calculator

Important Note

  • The below acceptable intake levels (AIs) have been established by the Non-clinical Working Party (NcWP) and, where applicable, determined using the Carcinogenic Potency Categorization Approach (CPCA).
  • These limits are applicable only if a FP contains a single N-nitrosamine.
  • The Acceptance Criteria - Concentration Limit (in ppm) has been derived based on the Allowable Intake (AI) in ng/day from EMA database current as of February 1, 2025.
  • The source refers to potential presence of nitrosamine impurities with structures derived from active substances or their related impurities. This does not mean that the impurity will be found in all products or pharmaceutical forms containing the named API. Please refer to Q&A on the risk factors for the presence of nitrosamines for further details.
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