Azopharma Methods Development & 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