ASTM International - ASTM E2549-09
Standard Practice for Validation of Seized-Drug Analytical Methods
|Publication Date:||1 April 2009|
|ICS Code (Laboratory medicine in general):||11.100.01|
significance And Use:
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. There are numerous documents that... View More
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. There are numerous documents that address the topic of validation but there are few validation protocols for methods specific to seized drug analysis. This standard makes recommendations for the validation of both qualitative and quantitative methods used for the analysis of seized drugs.View Less
1.1 This practice addresses the validation of qualitative and quantitative seized-drug analytical methods. It discusses the validation of analytical methods in terms of their part in analytical schemes and in terms of performance characteristics including brief mention of measurement uncertainty and quality control parameters.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.