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 Director of Drug Product Development at Adare Pharma Solutions and is responsible for pharmaceutical development activities at Adare’s Lenexa, KS and Philadelphia, PA facilities, where he supports 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.