What method accuracy criteria to be considered for nitrosamines, which guidance mentioned accuracy criteria?

Guidance, Documents, Resources
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What method accuracy criteria to be considered for nitrosamines, which guidance mentioned accuracy criteria?

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Hello, specific criteria (for methods validation) would still be ICH Q2 (R2) for guidance. In addition, GC <1469> has specific guidance for nitrosamines.

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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
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