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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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