Solid state analysis services
Holodiag offers solid state analysis services for solid state and physico-chemical characterization of Active Pharmaceutical Ingredients (APIs) and formulations.
Our laboratories are fully equipped with state-of-the-art analytical devices and our quality system allows us to perform analysis according to Good Manufacturing Practice (GMP) requirements. We can safely handle high toxicity samples with Occupational Exposure Levels (OEL) of 1µg/m3.
Holodiag’s solid state analyses mainly serve the following applications:
- Identification of solid states for both pure Active Pharmaceutical Ingredients (APIs) and final formulations
- Quantification of solid states, including crystalline and amorphous solid dispersions
- Stability and API/excipient compatibility studies
- Crystallinity measurement
- Method development and validation
Our in-house techniques include X-Ray Powder Diffraction (XRPD), Differential Scanning Calorimetry (DSC), Thermo-Gravimetric Analysis (TGA), Dynamic Vapor Sorption (DVS), Infrared (FTIR-ATR) and Ultra-Violet (UV) spectroscopy, polarimetry, Karl Fischer (KF), pH/pKa, potentiometry and HPLC-UV.
Additional techniques are readily available through our network of partners (e.g. SEM, PSD, NMR, BET).
Our analytical services are carried out under 5 working days within the framework of a strict quality system. Each analysis is delivered with a detailed report containing all the relevant comparisons, bibliographic search (patents, publications, crystal structures, etc.) and conclusions. We conjointly provide our customers with full scientific support for data interpretation and remain available for any additional details our customers would need.
We work according to the European Pharmacopoeia and can also work with specific customer methods.