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Pharmaceutical Method Development and Validation
Results from methods validation of pharmaceutical products are used to test the quality and reliability of results and the suitability of an analytical method. The method validation data is also required by legislation, the data is included in submissisons to regulatory bodies.
Pharmaceutical Method Validation to ICH guidelines is undertaken on customer methods, or in-house developed methods if requested.
The parameters that are validated are:
Linearity
Limit of detection (LOD)
Limit of quantification (LOQ)
Specificity (including stability of solutions)
Precision (method, intermediate and system)
Accuracy (recoveries)
Robustness
Forced Degradation
ILS will usually write the method validation and development protocol which is approved by the client before starting the work.
Contact ILS - for further information and pricing for method development and method validation.