Validation of analytical methods is a process used to demonstrate the suitability of the method in terms of reliability, accuracy, and precision for its intended purpose.
Validation is performed to ensure that the method used will produce similar results regardless of the time of analysis, the laboratory, or the analyst performing the analysis. This is especially important for methods used for routine quality control of raw materials, intermediates or finished dosage forms that must guarantee reliable analytical results.
INSLAB experts follow ICH guidelines for validation of methods and protocols, which include evaluation of the following parameters: accuracy, precision, specificity, limit of detection, limit of quantification, linearity, robustness and stability.
Proper validation means that the analytical method is tested to estimate the allowable variability of each parameter.
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