Your Development. Our Dedication.
Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, project management, and quality systems, Alcami’s cGMP analytical laboratories are arranged to maximize efficiency and deliver results.
Analytical Development, Validation, and Analytical Testing Services
- 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
- 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
Alcami has the flexibility to provide stand-alone analytical development solutions or comprehensive analytical support for pharmaceutical development programs.