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FDA panel says stress studies can substitute when nitrosamine reference standard cannot be made
Summary
FDA officials told industry that if stress studies show a nitrosamine cannot form, applicants need not supply a physical NDSRA standard; if it can form but the standard cannot be synthesized, sponsors must provide data and justified assumptions (for example, about relative response factors).
At an FDA technical meeting, an agency official said applicants can rely on stress studies to show a nitrosamine cannot form and avoid supplying an unavailable non‑drug substance reference standard (NDSRA).
"If you can prove that the molecule cannot be formed based upon stress studies...you don't have anything to worry about," the official said, describing that scenario as the first of two possibilities when a physical standard is unavailable. The official added that if the impurity can form but a standard cannot be synthesized, the sponsor will need to make assumptions—such as relative response factors—and provide supporting data in the application.
