1)write out detailed steps to explain how you would validate an analytical method which is used to characterise impurities 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 for Characterizing Drug Compounds Impurities 

An analytical method that characterizes impurities in drug compounds must be validated. To ensure that the validation of the method goes smoothly, there are several steps you need to take. First, it is important to document and justify the decision. It is important to identify and document all parameters, including selectivity, linearity and the range. To establish the linearity of the method within the test range, a number of analytes must be used. A linearity test is a method of determining the linearity of the method. This involves calculating the equation for the line and checking the accuracy of the method. The accuracy of the method should be verified. You can do this by using a reference standard. The results should then be statistically analysed. You can do it through. Cont…