Solid State Analysis
We are experts in solid state chemistry. Our highly skilled scientists have undertaken thousands of studies that range from routine analysis to challenging characterization under GMP studies.
- X-ray powder diffraction (XRPD)
- Hygroscopicity (DVS)
- Optical and digital microscopy
- Spectroscopy (FTIR, Raman, NMR, UV-vis)
- Differential scanning calorimetry (DSC)
- Particle size distribution (sieving, laser diffraction, image analysis)
- Thermogravimetry (TG)
- Single crystal structure determination
- Melting point determination
Data is presented in a report with interpretation and recommendations. GMP and rapid turnaround available.
We can develop and validate processes and methods to control and deliver the desired form during scale-up, troubleshoot existing problems, and generate intellectual property in line with regulatory requirements.
Our crystallization development team has the ability and expertise to help at all stages of crystallization development. We have extensive experience in validating crystallization parameters and testing process robustness. Our crystallization scientists consider the whole process and can undertake solid-liquid separation, washing, drying, and micronisation studies.
We have continued to strengthen our crystallization development capabilities by the acquisition of BlazeMetrics process analytical technology, which provides real time In-Process high resolution microscopy, analytics, and spectroscopy in a single probe, thus enabling us to better understand the critical parameters that affect crystallization and to develop robust, scalable crystallization processes.
Analytical Method Development and Validation
Regulatory authorities require an understanding of the processes that influence physical form and particle size and the means with which to monitor them more robustly. We are proficient in the development and validation of x-ray powder diffraction, thermal analysis and laser diffraction methods in order to support the control of the physical form and particle size distribution of late phase and commercial products.
With a wealth of experience in the solid state analysis and manufacture of drug substances and drug products, we are perfectly placed to rapidly troubleshoot any issues encountered over the entire life cycle of a drug, particularly particle size control and polymorph control.