Analytical Development
Alcami’s GMP analytical laboratories are arranged to maximize efficiency and deliver results - from the electronic laboratory notebook (ELN) data collection system to direct integration with formulation development, project management, and quality systems, we are equipped to meet your drug development needs.
Core Capabilities:
Drug substance and drug product stability indicating assays
Related substances, chiral purity, elemental impurity, and residual solvent analysis
Dissolution testing with UV and HPLC backend
Preservative and stabilizing excipients assays
Phospholipid and fatty acid analysis
Impurity ID and Structural Characterization
Particle Size Analysis
Physical and structural chemistry
Remedial method validation/method lifecycle evaluation studies
Drug substance and reference standard material characterization
Reference standard qualification
Process validation support
Cleaning method verification
Drug product comparator studies
Material contact studies
In-use and administration set compatibility studies
Extractables and leachables studies
Nitrosamine Testing
API polymorph screening
API salt form selection
API structural chemistry
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