Solid-State Characterization of Active Pharmaceutical Ingredients (APIs) and Excipients

Our analysis covers all pharmaceutical solid materials, including polymorphs, salts, solvates, hydrates, and co-crystals. Our expertise extends to amorphous solid dispersions and crystalline materials, delivering complete characterization across your development pipeline. The complete suite of solid state chemistry services can be jointly incorporated into both drug substance and drug product development programs. We specialize in analyzing drug-polymer combinations and complex pharmaceutical intermediates to support your formulation development. 

Key materials include: 

• Polymorphs and crystal structures 

• Amorphous solid dispersions 

• Drug-polymer combinations 

• Pharmaceutical intermediates 

• Crystalline and non-crystalline forms 

We provide comprehensive analysis of thermal properties, structure determination, polymorphism, and form conversion. Our testing capabilities include solubility and dissolution rate analysis, particle characterization, and contaminant identification using advanced microscopic techniques. We deliver detailed analysis of thermodynamic properties and phase transitions to enhance bioavailability, stability, solubility, processability, and other critical quality attributes to support your development decisions. 

Testing capabilities include: 

• Thermal analysis and decomposition studies 

• Structure and polymorphism determination 

• Particle size and shape analysis 

• Solubility and dissolution testing 

• Contaminant identification 

• Phase transition analysis 

Our solutions include polymorph screening, solid form selection, drug-polymer ratio analysis, and environmental factor impact studies. We deliver detailed microscopic evaluations and release testing for unwanted crystalline forms to support your development goals. Using crystallization screening techniques and considering critical material attributes, we optimize testing strategies based on your specific development stage and requirements. 

Our solutions include: 

Thermal analysis 

• Thermal decomposition 

• Melting point 

• Phase and glass transitions 

• Compound characterization 

• Thermodynamic properties 

• Degree of hydration or solvation  

Structure determination 

• Degree of hydration and solvation determination 

Polymorphism 

• XRD analysis of samples for polymorphism 

• Release testing of API for levels for unwanted crystalline forms 

Amorphous solid dispersion 

• Drug polymer ratio 

• Surfactant and solvent impact 

• Surfactant level 

• Solvent effect 

• Environmental factors (temperature and humidity) 

• Form conversion analysis 

Solid form selection 

• Solubility and dissolution rate 

• Thermal characterization 

• Particle size distribution 

• Particle shape 

Contaminant identification 

• Microscopic evaluations 

• Microscopic FT-IR evaluations and scans of contaminants  

• Scanning electron microscope (SEM) analysis 

• Energy dispersive x-ray spectroscopy (EDS) evaluation of elements present in materials 

Access state-of-the-art instrumentation including X-ray powder diffraction, Raman spectroscopy, differential scanning calorimetry, thermogravimetric analysis, FTIR spectroscopy, and scanning electron microscopy for comprehensive material characterization. Our advanced image analysis software enables detailed particle characterization and form identification. 

Available technologies: 

• X-ray powder diffraction (XRPD) spectroscopy 

• Raman spectroscopy 

• Differential scanning calorimetry (DSC) 

• Thermogravimetric analysis (TGA) 

• Fourier transform infrared (Micro-FTIR) spectroscopy 

• Light microscopy (LM) 

• Nuclear magnetic resonance microscopy (NMR) 

• Ultraviolet-visible (UV-Vis) spectroscopy 

• Scanning electron microscopy (SEM) 

• Image analysis software 

Our 8,500-strong team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page. 

Our consultative teams customize phase-appropriate testing protocols based on your specific API requirements, helping optimize solid forms to meet desired physical, chemical and biopharmaceutical properties. Our comprehensive testing helps to ensure quality and consistency of solid-state materials used throughout development, formulation and clinical manufacturing. We work closely with your development team to expedite timelines while maintaining rigorous scientific standards and regulatory compliance.