Since compendial methods cannot encompass all possible formulations of a drug product, the
applicability of a compendial method to a company’s particular formulation of a drug product must be
demonstrated. It must be determined that there is nothing in the product that causes an interference with the
compendial method or affects the performance of the method. It must also be established that the impurities
that would be expected from the route of synthesis or formulation are controlled by the compendial method.
The main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for
its intended purpose.
