- • Development of stability indicating method for assay, impurities, dissolution and residual solvents tests (including isomeric separations)
- • Complete validation of analytical method as per ICH guidelines
- • Analytical method transfer (AMT) as per customer’s requirement
- • Dissolution profiling in three different media and impurities profiling and comparison with innovator/marketed product
- • Elemental and nitrosamine impurities method development, validation and testing
- • Stability studies of newly developed product as per ICH guidelines to establish its shelf life
Analytical method development, validation and stability studies as per ICH guidelines
Our analytical method development strategy is to develop a short and economical analytical method without compromising its accuracy, precision, sensitivity and reproducibility and validate the developed method as per ICH guidelines requirements. We closely monitor analytical methos development and validation related activities at our qualified and properly selected CROs to make sure that the developed method fulfills its purpose.
Our comprehensive analytical method development and validation activities includes –
