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Analytical Method Development is the process of designing, refining, and validating a procedure to accurately, precisely, and consistently detect, identify, and quantify specific analytes within a given sample. This process is fundamental in various industries, including pharmaceuticals, chemicals, environmental testing, and food safety, where reliable analytical results are critical for product quality, regulatory compliance, and safety assurance.
The method development process involves selecting appropriate analytical techniques (such as HPLC, GC, UV-Vis, or spectroscopy), optimizing parameters like solvent systems, detection wavelengths, and flow rates, and ensuring the method is robust, reproducible, and suitable for its intended purpose.
Once developed, the method undergoes validation to confirm performance characteristics such as accuracy, precision, specificity, linearity, limit of detection (LOD), and limit of quantification (LOQ). A well-developed analytical method ensures confidence in the results and supports informed decision-making throughout product development and quality control.
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