What method accuracy criteria to be considered for nitrosamines, which guidance mentioned accuracy criteria?
Hello, specific criteria (for methods validation) would still be ICH Q2 (R2) for guidance. In addition, GC <1469> has specific guidance for nitrosamines.
Please remember that FDA/EMA guidance provided specifics of analytical procedure requirements as well.
FDA Control of Nitrosamines Impurities in Human Drugs - Guidance for Industry - FDA February 2021
- Products with MDD < 880 mg/day: LOQ ≤ 0.03ppm
- Products with MDD > 880 mg/day: LOQ as low as reasonably practical
- LOQ < Test Result ≤ Acceptable Intake
EMA Assessment Report - Nitrosamines Impurities in human medicinal products - EMA 25June20
- LOQ ≤ Acceptable limit for the respective nitrosamine impurities, taking into account the purpose of testing
- Routine control: LOQ ≤ Acceptable Limit
- Justify skip testing: LOQ ≤ 30% of AL
- Justify omission from the specification: LOQ ≤ 10% of AL