1)write out detailed steps to explain how you would validate an analytical method which is used to characterise impurties in a drug compound prior to its use? 2) explain the use of process analytical technology through process validation , include examples? Validating Analytical Methods to Characterise Impurities in Drug Compounds

Validating Analytical Methods to Characterise Impurities in Drug Compounds

When validating an analytical method used to characterize impurities in a drug compound, it is important to ensure the method is reliable, accurate, and reproducible, and will produce reproducible results when used in a routine laboratory setting. There are a few steps that must be taken to ensure the method is validated correctly. First, the selection of the method must be justified and documented. All parameters should be identified and documented, such as selectivity, linearity, and range of the method. The method must be tested with a series of known concentrations of the analyte to establish its linearity within the range of concentrations that will be tested. This can be done through a linearity test, where the equation of the line is calculated and the linearity of the method is checked. Next, the accuracy of the method must be established. This can be done through the use of a known reference standard and the results must be statistically analyzed. This can be done through. Cont…