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

Reduce the cost and time associated with drug product development by determining and selecting an optimal solid form for performance, processability, stability and manufacturability with Element’s expertly designed solid-state characterization studies, delivered by dedicated teams of pharmaceutical scientists with extensive advanced chemical synthesis knowledge.

A phase-appropriate solid-state analysis strategy early on in development, purposefully designed to accelerate timelines, will ensure that all viable options are considered, and an optimal lead solid form is selected. Our complete suite of solid-state chemistry services can be easily incorporated into both drug substance and drug product development programs. Consistent drug product manufacturing, formulation viability and patent protection require a comprehensive understanding of the solid-state characteristics and behavior of active pharmaceutical ingredients (APIs) and excipients, which may exist in a variety of solid forms, including salts, solvates, hydrates, co-crystals and polymorphs.

Selecting the best available solid state candidate is a critical aspect of pharmaceutical development, as different forms or crystal structures (polymorphism) can exhibit distinct functional properties and behaviors, impacting physical and chemical stability, solubility, bioavailability, reactivity, and more. Drug polymorph screening techniques are remarkably effective at identifying and characterizing solid-state forms of substances, facilitating the development of methods to ensure the quality and consistency of solid-state materials used throughout development, formulation and clinical manufacturing.

Comprehensive solid-state characterization services

Element’s expertly designed solid-state characterization services draw from a breadth of expertise which has been built upon a foundation of wide-ranging physical processing techniques and characterization, synthesis, and materials science knowledge, which extends to an array of diverse disciplines.

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

Advanced instrumentation

• 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

The Element advantage

With a comprehensive range of solid form screening solutions and instrumentation, our consultative teams of experienced scientists customize phase-appropriate testing protocols and screening activities based on the functionalities of specific intermediates and APIs. Element has a demonstrated track record of success optimizing solid forms to meet desired physical, chemical and biopharmaceutical properties, expediting development timelines and extending pharmaceutical product life cycles.

To learn more about our solid-state analysis services and solutions, or to speak with one of our experts, contact us today.