SSCI, a division of AMRI that provides global analytical services, implements Mettler-Toledo’s thermal analysis instruments that meet updated data integrity standards being enforced by regulatory agencies in the United States and European Union as of 2018.
Having this new thermal analysis capability:
- bolsters our support for crystalline form characterization
- provides our scientists with the ability to obtain valuable information about the thermal properties of materials
- further enhances the information that we deliver from polymorph, salt and co-crystal screens
- provides a systematic approach to amorphous solids characterization and drug-polymer miscibility for designing enabling solid dispersion formulations at a standard that is unmatched in the contract solid-state and analytical services industry when coupled with SSCI’s existing isothermal and microcalorimetry capabilities, the resulting data and corresponding expertise in solid-state chemistry
- further enables us to provide high quality cGMP data that meets data integrity regulations
AMRI SSCI’s Thermal Analysis Systems and Capabilities
Monitoring thermochemical events and weight loss as a function of temperature can give valuable insight into solid form characteristics, mechanisms of polymorphic transformations, and solid-state degradation pathways. SSCI uses modern differential scanning calorimetry (DSC) and thermal gravimetric instrumentation (TGA) to analyze these properties of bulk and formulated solid products.
The Mettler-Toledo instruments at SSCI now include models TGA / DSC 3+, TGA / SDTA851e, DSC 3+, and DSC 822. These systems, which became operational in December 2017, provide direct access to high-quality thermal analysis data as a stand-alone service offering.
Increased heating and cooling rates across the entire temperature range typically relevant to organic materials are used to investigate fast and slow solid state phase transitions. Stochastic modulated differential scanning calorimetry (DSC) allow results to be obtained using random-width temperature pulses to investigate in a single analysis which events are frequency-dependent (such as glass transition temperatures) and which are not (such as melting temperatures). Simultaneous thermogravimetry (TGA) and DSC provides the ability to collect heat flow and mass change information under identical conditions. This Mettler-Toledo technology also enables isoconversional solid state kinetics to be measured to predict time and temperature iso-conversion curves, as well as quantitative calorimetry measurements for heats of reaction, heats of fusion and heats of transformation.
These capabilities further enable AMRI’s ability to deliver advanced understanding of solid-state properties, such as free energy-temperature diagrams to understand the thermodynamic relationship(s) of polymorphic systems, understanding the fate of hydrate/solvate crystalline forms on loss of solvent of crystallization, and co-crystal characterization.