Practical sheet | REF: FIC1420 V1

The accuracy profile method

Author: Max FEINBERG

Publication date: April 10, 2015 | Lire en français

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    2. Define the scope of the method to be validated and quantify the objectives

    As an illustration, we will use the validation study of a method for determining nicotinamide (a vitamin B 3 vitamin) in milk by HPLC, with quantification by external calibration.

    • The natural content of nicotinamide in milk is between 0.6 and 1.0 mg L - 1 ; regulations authorize supplementation, ranging from 0.4 to 2.0 mg L - 1 . The chosen validation range is therefore between 0.4 and 4.0 mg L - 1 .

    • There is no official reference for setting the acceptability limits of this method. However, the microbiological reference method has a high uncertainty of ± 40%. To demonstrate that the HPLC method can easily be an alternative to the reference method, acceptability limits...

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    Define the scope of the method to be validated and quantify the objectives