Method Development And Validation

Cyanta expertise in method development spans all areas from early to late phase drug and medical device development programs. We can develop methods for material comparison and composition as well as problem solving and failure investigation for all stages of program development.

Our method development capabilities include:

• Drug substances and excipients
• Oral dosages (tablets, capsules)
• Topical dosages (creams, ointments, lotions)
• Liquid dosages (solutions and suspensions for oral, ophthalmic, otic and parenteral delivery)
• Transdermal Patches
• Inhalation dosages (MDI, DPI, Nasal)

After a successful method development, we can validate your analytical method per appropriate ICH guidelines. Cyanta's scientists frame their method validation activities with a practical approach coupled with outstanding quality and sound scientific expertise. Typical characteristics include:

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