Method Development & Validation

At CA Analytical Testing Services, we collaborate closely with clients to create analytical methods tailored to their specific validation requirements. Whether you are launching a new product, investigating impurities in an existing one, or identifying leachable compounds in a drug formulation, our scientists work alongside your in-house experts to fully support your development and validation needs.

When designing new methods, it is essential to first ensure the analytes of interest are clearly identifiable before moving into validation studies. The method must not only detect these analytes but also quantify them accurately without interference from other components in the sample matrix. Our Senior Scientists partner with clients to select the most suitable analytical technique—drawing on a complete understanding of the manufacturing process, the matrix composition, and potential interfering substances ensuring our clients have a robust and accurate analytical method to support the life of the product.

Leveraging our extensive expertise, we design scientifically defensible testing protocols that can withstand regulatory review. Our laboratory develops methods using the most appropriate sample preparation and analysis approaches to detect the target analytes. Once an optimal method is established, we provide a detailed protocol and evaluate it in accordance with ICH guidelines to ensure full compliance.

For every new method CA Analytical develops, we evaluate key performance characteristics, including:

• Specificity – the ability to distinguish the analyte from other components in the matrix.
• Accuracy – how closely the results match the true or accepted value.
• Precision – covering both repeatability and intermediate precision to ensure consistency of results.
• Linearity – the method’s capability to produce results proportional to analyte concentration.
• Range – the span between the lowest and highest concentrations that can be measured with acceptable accuracy and precision.
• Limits of detection and quantification – the smallest amount of analyte that can be reliably detected and accurately quantified.
• Robustness – the method’s resilience to small, deliberate variations in test conditions.
• Stability of test solutions – the ability to maintain integrity of prepared samples throughout the testing period.