SOLID-STATE CHARACTERIZATION

Alcami's solid-state characterization services include stand-alone services to full development support.

Alcami offers a full suite of solid-state characterization capabilities to advance our customers' knowledge of their compounds, progress clinical candidates, and extend intellectual property. From stand-alone solid-state characterization services to full development support, we have the technical expertise and technologies to support our clients in the discovery of novel polymorph, salt, and cocrystal forms and in the development of robust crystallization and formulation processes. Alcami provides customizable and innovative solutions with a seamless transition from initial characterization through GMP manufacturing and analytical release.

CORE SERVICES 

  • Polarized-light microscopy: Birefringence, size, and habit
  • Powder X-ray diffraction: Presence/absence of crystallinity and unique diffractogram
  • Thermogravimetric analysis: Weight loss due to solvent and/or decomposition
  • Differential scanning calorimetry: Melting of crystals, glass transition of amorphous, relative stability of polymorphs
  • Dynamic vapor sorption: Hygroscopicity
  • Crystallization screen: Aiding isolation and purification
  • Polymorph screen: Discovery, evaluation, and recommendation of optimal polymorph for development
    • Hydrate studies: phase diagrams to support robust formulations and manufacturing operations
    • Solvate studies: phase diagrams to support robust crystallization process
  • Salt screen: Discovery, evaluation, and recommendation of salts with optimized dissolution/bioavailability
  • Cocrystal screen: Discovery, evaluation, and recommendation of cocrystals with optimized properties for non-ionizable APIs
  • Small scale preparation (<5g) of API materials: Support for PK, tox, and developability studies & preview of crystallization process conditions
  • Single-crystal growth and single crystal X-ray diffraction: Atomic connectivity, absolute configuration, crystal packing and aiding in-depth understanding of crystal nature and bulk properties
Solid State Characterization
WHITEPAPER: Pharmaceutical Solid-State Studies
CASE STUDY: Solid-State Characterization of a Small Molecule API
 

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