We produce a full API characterisation, which includes NMR, XRPD, DSC, TGA, DVS, FTIR, hot stage and polarised microscopy, aqueous solubility, also pH and a simple HPLC analysis to begin to understand purity. This starting data provides a benchmark to begin to understand the material “as is” and where the key challenges lie, and how they can be addressed. All of this work is carried out by our scientists within GMP-controlled laboratories.
Also at this stage a limited version of our excipient solubility screen can be used to provide an understanding of the extent of solubility of the API in a range of solvents and excipients. This also gives an indication of the possible ways any problems can be resolved.
Other work at this stage will be to investigate the physical and chemical stability of the API looking at techniques such as XRPD, FTIR, Raman, NMR and HPLC to determine changes in the API. We are also able to look at dissolution, permeability and solubility in a range of conditions which mimic physicochemical conditions.
Concept Life Sciences uses over 30 different methods as part of its material characterization service. The technique used is matched to the information needed and the form the sample is in. The more common techniques are for the analysis of solid samples but liquid and gas sampling can also be carried out.
Materials characterization can be particularly useful for thin film analysis, depth profiling and crystallinity.
Regulators are requiring tighter control over physical parameters such as particle or droplet size, viscoelastic properties and the correlation of these parameters to efficacy. We can help you understand the physical properties of a pharmaceutical product by providing the data required to make informed decisions. Our team can carry out all aspects of physical characterization testing from crystal habit to particle morphology, solubility, particle size analysis and crystal polymorphism.
Our fully equipped laboratories are equipped to determine:
- Particle size via dynamic light scattering (DLS)
- Particle size via laser diffraction
- Particle size via X-ray disc centrifuge
- Particle charge (zeta potential) by electrophoretic light scattering
- Particle charge (zeta potential) by phase analysis light scattering
- Rotational rheometry
- Squeeze flow rheometry
- Tensile and tack testing
- Dynamic contact angle
- Surface tension
- Differential scanning calorimetry
- Thermogravimetric analysis
- Contact angle/surface energy measuring system
- Turbiscan sedimentation-stability analyser
- HPLC with ultraviolet, photo diode array, refractive index, evaporative light scattering detectors
- UV/VIS spectrometer
- ICH temp/humidity stability chambers
- ICH photostability chambers
- LC/MS ion trap
- LC/MS triple quad
- Microscopic image analysis
- Karl Fischer titration (Coulometric and volumetric)
- Total organic carbon analyzer
- Horiba Raman/particle characterization system
While biological testing will provide clear pass/fail criteria for the tests performed on medical devices, the material characterization tests will generate data on the potential chemical compounds that can leach out during the medical use of the device under “worst case” simulation conditions. For this reason identification of material chemical constituents and chemical characterization of the materials should precede any biological testing.
We provide a full chemical characterization service. Our team can help design the right testing strategy for a medical device. We will calculate the Thresholds of Toxicological Concern (TTC) and help interpret and report data. Our comprehensive biocompatibility/Material Characterization Risk Assessment report looks at the medical/clinical use, exposure time, age and pharmacokinetics of the device.