Method Development & Validation
Azopharma specializes in providing method development for early to late phase developments and developmental methods for the purpose of material composition and characterization. We also specialize in early phase problem solving and late phase failure investigations. 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)
- Medical devices (implants, drug delivery systems, containers and protective devices)
After a successful method development, Azopharma can validate your analytical method per appropriate ICH guidelines. Our scientists frame their method 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