Method Development and Validation

Analytical method development and validation services are offered in compliance with current ICH guidelines. The validations are done for all the parameters as per ICH guidelines. The dedicated validation group is equipped with the following analytical techniques:

• HPLC with UV-visible/ Fluorescence/ PDA/ RI Detectors
• GC and HSGC with FID/TCD/MS detectors
• LC/MS-MS
• Ion Chromatography
• AAS and ICP-MS

Method development is undertaken for:

• Assay
• Dissolution
• Impurities
• Trace metals
• Residual solvents
• Physico-chemical tests

We also undertake complete impurity profiling of pharmaceuticals.