Can everyone help me why in low doses of a drug grow impurity, but for the same drug in higher dose we have no impurity with over time?
Hi,
Please check the analytical method for control of these impurities. For the same drug in higher doses, there may be no impurity over time because the impurities may be present in such small amounts that they are not detectable by the analytical methods used (another baseline shift related to the presence of a high concentration of drug product). It may be method-related especially in the case of optical detection like UV, PDA, FL etc., and if the method does not cover in preparation of the sample any extraction method (separation of signals related to drug substance and impurity). Double-check with mass spectrometry if possible.
Best regards
Tomasz
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