Guidelines for the Design, Implementation, and Interpretation of Validations for Chromatographic Methods used to Quantitate Leachables/Extractables in Pharmaceutical Solutions

Abstract

This paper deals with validation of chromatographic methods for quantitation of leachables and extractables in pharmaceutical solutions. Guidelines are presented for designing, implementing, and interpreting validations.

Keywords:

• Validation
• Chromatographic methods
• Design
• Implementation
• Interpretation
• Leachables
• Extractables
• Pharmaceutical solutions