Chemical Requirements

What should be included in a migration study report submitted with an FCN?

Mar 2001

Question: What should be included in a migration study report submitted with an FCN?

Answer: The testing should be described in detail, including sample preparation, experimental design, analytical or test methods, and validation procedures. The report should show representative calculations and include calibration curves. Representative chromatograms should also be included in the report. Generally, the results should be reported in units of amount per surface area, e.g., mg/in².

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