Product Development Services- Methods Development and Validation

Methods Development Services
Scientists at our cGMP compliant drug development facilities are equipped with an array of tools and techniques including HPLC, LC/MS/MS, TLC, GC, GC/MS, IC, GPC and ICP-MS to develop and optimize methods.

Azopharma develops analytical methods for the following applications:

• Potency
• Dissolution
• Impurities
• Moisture
• Metals
• Residual solvents
• Physical and chemical tests
• Cleaning assessment
• DMF updates
• Bioanalysis
• Others as requested

Validation Services
After a successful method development, Azopharma can validate your analytical method per
ICH guidelines. Our scientists frame their methods validation activities with a practical approach
coupled with outstanding quality and sound scientific expertise. Typical characteristics include:

• Filter/Flush evaluation
• Method precision (intermediate and reproducibility)
• Limit of detection
• Limit of quantitation
• Flush volume studies
• Accuracy and recovery studies
• Linearity and range
• Specificity, including forced degradation analysis
• Robustness
• Solution stability