The FDA’s Revision 1 Guidance for Industry on the Control of Nitrosamine Impurities in Human Drugs released in 2021 stipulates that when MDD is less than 880mg, it should be calculated as 880mg, and the LOQ should not exceed 0.03 ppm;
The Revision 2 released in September 2024 seems to have cancelled this regulation.
Who can confirm the reason for this revision? What is the best practice for enterprises?
Just divide the Acceptable Intake of the nitrosamine in ng/day by the MDD in mg/day, and the result would be the specification in ppm.
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