Expert development and validation of analytical methods for quality control and research.
Development of robust HPLC methods for various applications including assay, impurity profiling, and dissolution testing.
Development of UV-Vis methods for quantitative analysis and identification.
Development of gas chromatography methods for volatile compounds and impurities.
Validation according to ICH Q2(R1) guidelines for pharmaceutical analysis.
Assessment of specificity, linearity, accuracy, precision, robustness, and other parameters.
Transfer of analytical methods between laboratories and sites.
Comprehensive documentation and training materials for method transfer.
Initial method development and optimization
Assessment of method specificity and selectivity
Determination of linear range and calibration
Repeatability and intermediate precision assessment
Evaluation of method robustness and system suitability
Preparation of validation report and method documentation
We can help you develop and validate analytical methods for your specific products. Let's discuss your requirements.
Let's Talk About Your Methods