Method Development and Validation

Analytical method development and validation services are offered in compliance with current industry and regulatory standards.

Our trained and experienced analysts are equipped with the following analytical techniques:

• HPLC with UV-visible/ Fluorescence/ PDA/ RI/ ECD
• GC
• GC/MS
• GC/MS-MS
• LC/MS-MS
• AAS, ICPAES, ICP-MS

Method development is undertaken for:

• Assay
• Dissolution
• Impurity profiling
• Trace metals
• Residual solvents
• Physico-chemical tests

Method validations are carried out as per ICH guidelines to cover:

• Accuracy
• Precision
• Repeatability
• Intermediate precision
• Robustness
• Limit of detection
• Limit of Quantitation
• Ruggedness