Qualification and Validation

At CuriRx, we believe that a well-developed method should be easy to qualify and validate. The validation/qualification protocol will list the system suitability and acceptance criteria that the method can meet.

Our expert analytical chemists ensure that you will receive a robust, transferable, stability-indicating HPLC method that is tailored to your product development needs and the required validation/qualification parameters. Depending on the stage of clinical trial, this a method can be fully or partially validated.

Qualification and validation requirements depend upon several testing method factors:

Specificity: ability to measure desired analyte in a complex mixture
Accuracy: agreement between measured and real value
Linearity: proportionality of measured value to concentration
Precision: agreement between a series of measurements
Range: concentration interval where method is precise, accurate, and linear
Detection limit: lowest amount of analyte that can be detected
Quantitation limit: lowest amount of analyte that can be measured
Robustness: reproducibility under normal but variable laboratory conditions

A simple identification test typically only requires specificity; the full range of testing requirements is needed for more-complex methods (e.g, quantitative impurity).

Method qualification/validation is a continuous process. Our goal is to ensure your confidence in the analytical data throughout product development. Upon completion of the methods development process, our scientists will provide you with a technology transfer package that summarizes the final validation/qualification report and test method.