Hi, Probable Nitrosamine that can form in my drug product is NDMA which has an AI of 96 ng/day & my drug product Maximum daily dose is 7.5 g/day, the derived spec for the said Nitrosamine is 12.8 ng/g. Then why developing an analytical method for confirmation testing what should be my ideal Standard concentration for NDMA if my tentative method has developed with sample concentration of 5000 ppm. Can anyone kindly walk me through as per guidance?
I always begin analytical method development by establishing the instrument’s LOD/LOQ, followed by verifying the LOD/LOQ for the method itself. I assume the LOQ to be 10% of the specification value and validate the method’s linear range from 10% to 150% of the specification. Finally, I calculate the required sample preparation concentration based on an analyte concentration equivalent to 100% of the specification value.
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@Koumine Thanks for sharing your approach… very practical!
@jagan3862 I suggest your review the multiple application notes from the analytical hub here in the community, that can provide a solid approach to your analytical development. Topics tagged Analytical-Hub
Also please refer to the peer-reviewed article authored by several regulatory representatives in the same topic.
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Thanks for the insights provided for the topic and the response was highly appreciated.