Validate an Analytical Method

Formal validation of a chromatographic analytical method following ICH Q2(R2) guidelines, covering validation scope definition by method category, specificity/selectivity establishment, linearity and range determination, accuracy and precision assessment, and LOD/LOQ and robustness studies for regulatory compliance.

When to Use

• A new chromatographic method has been developed and must be validated before routine use
• A compendial method is being verified for suitability in a specific laboratory
• An existing validated method has undergone significant changes requiring partial or full re-validation
• Preparing a validation package for regulatory submission (NDA, ANDA, MAA, IND)
• Transferring a method to a new laboratory or instrument platform

Inputs

Required

• Developed method: Fully optimized and documented chromatographic method (column, mobile phase, gradient, detector, etc.)
• Method category: Assay of active ingredient, quantitative impurity test, limit test for impurities, or identification test
• Analyte reference standards: Primary reference standards with certificates of analysis and assigned purity