Description
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
Chromatography, Dissolution, and Monograph techniques
USP/NF, ASTM, EP, BP, JP and CP
On-Site GMP Testing
Active Pharmaceutical Ingredients
Excipients
Finished Product
Stability & Storage
Large capacity stability storage and testing under ICH-controlled conditions
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
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