For chromatography and mass spectrometry groups, the most important recent change in the nitrosamine field is not simply that the limits got tighter.1-3 It is that the analytical target has become less generic. The field has moved away from a narrow focus on a short list of classic, small nitrosamines and toward API-specific nitrosamines, nitrosamine drug substance-related impurities, packaging-linked risks, and matrix-dependent confirmation problems. This change has direct consequences for how methods are selected, developed, and validated.1-3,8