A full suite of expert services to navigate the complex world of analytical methodology
Adare Pharma Solution’s team of analytical experts provide experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
Analytical Method Development and Phase-Appropriate Method Validation
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- Chromatography, Dissolution, and Monograph techniques
- USP/NF, ASTM, EP, BP, JP and CP
On-Site GMP Testing
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- Active Pharmaceutical Ingredients
- Excipients
- Finished Product
Stability & Storage
Large capacity stability storage and testing under ICH-controlled conditions
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- 25°C, 60% RH
- 30°C, 65% RH
- 30°C, 75% RH
- 40°C, 75% RH
- ICH-compliant photostability studies
Small Molecule Evaluation
Stability-Indicating Assays
R&D Analytical Instrumentation
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- HPLC and UPLC with UV, PDA, CAD (Corona Charged Aerosol Detection), RI, and ELS (Evaporative Light Scattering) detection
- UPLC/MS/MS Ion Trap Mass Spectrometer (with electrospray and atmospheric pressure chemical ionization (APCI) sources)
- Dissolution (bio-relevant and QC test); including USP 1, 2, 3, and 4 capabilities
- GC Headspace and Direct Injection
- Spectrophotometry: UV/VIS, FTIR, Raman, Near IR
- ICP/MS
- Various physical testing capabilities including Malvern laser particle size
- Microscopy (SEM, FTIR, and digital), QIC-PIC, and texture analyzer
Speak With An Expert
Nathan Dormer
Director, Drug Product Development
Nathan Dormer, Ph.D., is the Senior Director of Drug Product Development & Site Leader at Adare Pharma Solutions and is responsible for pharmaceutical development activities at Adare’s facilities, supporting a team of formulation scientists and analysts. He is a pharmaceutical scientist and bioengineer by training, with more than 16 years of experience developing microsphere-based solid oral and parenteral/implantable dosage forms in academic, innovator, and CDMO settings. Dr. Dormer earned his B.S. in Chemical Engineering and his Ph.D. (w/Honors) in Bioengineering from The University of Kansas while receiving NIH-sponsored Pharmaceutical Biotech Training.