Method Development & Validation

ILS Limited Method Development & Pharmaceutical Method ValidationILS Pharmaceutical Chemistry Laboratory perform Pharmaceutical Method Development and Pharmaceutical Validation to ICH guidelines and is undertaken on customer methods, or in-house developed methods if requested. We will write the method validation and development protocol which is approved by the client before starting the work.

Results obtained from method 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 submissions to regulatory bodies.

The parameters that are validated are:

Accuracy
Precision (repeatability, intermediate precision & reproducibility)
Specificity
Limit of Detection (LOD)
Limit of Quantification (LOQ)
Linearity
Range
Robustness
Solution Stability

 

We pride ourselves on customer service and value all of our customers please contact us to see if we can help you with your pharmaceutical testing requirements.