Hi every body
what is test validation parameters required to validate identification analytical method of drug substances? How we determine specificity and accuracy , if required
Mohammed Yacout:D
Hi every body
what is test validation parameters required to validate identification analytical method of drug substances? How we determine specificity and accuracy , if required
Mohammed Yacout:D
you perform analytical method validation parameters as per ich and USP.In specificity you have to perform individual identification solutions (std,sample,impurites) and no need to perfom accuracy for drug substance