Nitrosamine Impurity Calculator

Based on ICH M7 / FDA / EMA guidelines

Calculate the nitrosamine specification limit in the drug product (ppm) from the Acceptable Intake (AI) and the Maximum Daily Dose (MDD).
Common Nitrosamine Acceptable Intakes (ICH M7 / FDA)
CompoundAbbr.AI (ng/day)
N-Nitrosodimethylamine (NDMA) NDMA 96
N-Nitrosodiethylamine (NDEA) NDEA 26.5
N-Nitrosomethylbutylamine (NMBA) NMBA 96
N-Nitroso-N-methyl-4-aminobutanoic acid (NMBA/NMPA) NMPA 96
N-Nitrosoisopropylethylamine (NIPEA) NIPEA 26.5
N-Nitrosodiisopropylamine (NDIPA) NDIPA 26.5
N-Nitrosodibutylamine (NDBA) NDBA 26.5
N-Nitroso-N-ethylisopropylamine (NEiPA) NEiPA 26.5
N-Nitrosobenzylmethylamine (NMBzA) NMBzA 26.5
N-Nitrosodiethanolamine (NDELA) NDELA 26.5
N-Nitrosotetrahydrothiophene (NTTP) NTTP 1500
Formulas

Limit (ppm): AI (ng/day) ÷ MDD (mg/day)

Content (ppm): (Asample / Astd) × Cstd (ng/mL) / Csample (mg/mL) × DF

Daily Intake (ng/day): Content (ppm) × MDD (mg/day)