Establishment Acceptance Limit for Nitrosamine impurities :

Establishment of the AIs with The Carcinogenic Potency Categorization Approach (CPCA) for N-nitrosamines

It is used for NDSRIs and new  identified impurities which are not published by HA.

AI value considered by following the CPCA approach recommended in EMA guidance

 

Calculation Formula for acceptable limites

AI (ng/day) / Maximum Daily Dose (mg/day) = Limit in ppm.

e.g.: AI Limit is 1500ng/day and MDD is 100 mg/day

Acceptable Intake (AI) Standard Limits

NDMA - 96 ng/day

NDEA - 26.5 ng/day

EIPNA - 26.5 ng/day

DIPNA - 26.5 ng/day

NMBA - 96.0 ng/day

MeNP - 26.5 ng/day

NDBA -  26.5 ng/day