Method validation is the process by which it is established that the performance of an analytical method meets the requirements for its intended purpose.

Methodology

Efficient development of high-quality chromatographic methods (HPLC or UPLC) is performed using Analytical Quality by Design (AQbD) approaches. The final methods are validated to ensure that they meet the requirements for their intended use, and this process is carried out under GLP compliance.

Typical analytical characteristics used in method validation follow ICH guidelines for

• Linearity
• Precision (repeatability and intermediate precision)
• Accuracy
• Specificity
• Limit of detection and limit of quantification
• Range
• Robustness and stability of test solutions

Turn-around time: 4 weeks