We're glad you stopped by Select the correct response The detection limit must be determined A in every repeatability study within a method validation B in every pharmaceutical HPLC method. This page is here to walk you through essential details with clear and straightforward explanations. Our goal is to make your learning experience easy, enriching, and enjoyable. Start exploring and find the information you need!
Answer :
Final answer:
The detection limit is necessary in every robustness study when quantifying trace levels of impurities or degradation products of an active pharmaceutical ingredient. It defines the lowest quantity that can be distinguished from the absence of that substance.
Explanation:
The correct response to the question concerning the scenario in which the determination of the detection limit is necessary is option c) 'In every robustness study when quantifying trace levels of impurities or degradation products of an active pharmaceutical ingredient'.
Detection limit is an essential parameter in analytical chemistry, especially in pharmaceutical HPLC method validation, as it defines the lowest quantity of a substance that can be distinguished from the absence of that substance.
In carryout out a robustness study, especially when it involves the quantification of trace levels of impurities or degradation products, the detection limit becomes vital as it determines the smallest concentration that can be reliably measured.
The correct question is:
The determination of the detection limit is necessary for which scenario?
a) In every repeatability study within a method validation
b) In every pharmaceutical HPLC method validation
c) In every robustness study when quantifying trace levels of impurities or degradation products of an active pharmaceutical ingredient
d) In reproducibility studies
Please select the correct response from the options above.
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