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 in Lenexa, KS. Dr. Dormer is a pharmaceutical scientist and bioengineer with over a decade of experience developing microsphere-based solid oral and parenteral/implantable dosage forms, with an emphasis on controlled release and other innovative formulation concepts. He is responsible for pharmaceutical development activities such as creation of prototypes, analytical method development, CMC and IP documentation, pharmacokinetic correlations, tech transfer, manufacture of clinical supplies, and commercial scale process optimization and validation. Dr. Dormer received his B.S. in Chemical Engineering and his Ph.D. with Honors in Bioengineering, both from The University of Kansas.
