Hello Dear Friends,
I crushed tablets containing water-insoluble API and then dissolved this tablet powder in water. But you know that my API is not soluble in water. Do I have to dissolve the API for nitrosamine analysis? Most of the nitrosamines are water-soluble. Therefore, the nitrosamines in my tablet powder will dissolve in water. Could you comment on this issue?
The challenge on sample preparation is not just about the API and the impurities. It truly is about the entire matrix of the sample. Regardless of your extraction protocol, you need to demonstrate that EVERY impurity has been extracted 100%. Your validations should answer that question
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