We're glad you stopped by In which context is the statement The detection limit must be determined correct A In every repeatability study B Within a method validation C In. 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 statement is correct within a method validation and when quantifying trace levels of impurities or degradation products.
Explanation:
The statement "The detection limit must be determined" is correct within a method validation context and when quantifying trace levels of impurities or degradation products of an active pharmaceutical ingredient in reproducibility studies. In method validation, the detection limit is an important parameter that helps assess the sensitivity and accuracy of the analytical method being used. It indicates the lowest concentration of an analyte that can be reliably detected and quantified. For pharmaceutical high-performance liquid chromatography (HPLC) method validation, determining the detection limit is essential since it ensures the method's capability to detect impurities or degradation products at trace levels, which is crucial for pharmaceutical quality control.
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