Holodiag provides analytical services for solid state and physico-chemical characterization of Active Pharmaceutical Ingredients (APIs) in drug substances and drug products.
Quality assurance
A robust system allows management of qualification, calibration, checking of device, recording of data and more. We work according to the European Pharmacopoeia and can also work with specific customer methods.
Physico-chemical analyses
Holodiag’s solid state analyses serve the following applications:
Solid state identification: hydrates, solvates, salts, co-crystals, amorphous
Solid state quantification: crystalline and amorphous
Particle size distribution
Method development and validation
Routine QC
Accurate and complete analytical report
Our analytical services are tipically carried out under 5 to 7 working days within the framework of a strict quality system. Each analysis is delivered with a detailed report containing all relevant comparisons, bibliographic search (patents, publications, crystal structures, etc.) and conclusions. We provide our customers with full scientific support for data interpretation and remain available for any support and discussion on the results.
Variety of samples studied
Various samples can be analyzed, from pure API to final formulation (e.g powders, suspensions, tablets, oitments, suppositories, lyophilisates, pomades and more). We can safely handle high toxicity samples with Occupational Exposure Limits (OEL) of 50 ng/m3.