Instrumental analytics
Tentamus Pharma & Med tests the safety of medical devices as part of development, registration and market surveillance.
Tentamus Pharma & Med’s laboratories conduct chemical and instrumental tests in order to analyse raw materials, semi-finished goods and finished batches of medical devices. We perform qualitative and quantitative limit and content determination for a wide variety of substances such as residual solvents, heavy metals and endotoxins. We detect contamination with foreign matter and verify the sterility of medical devices.
Chemical characterisation
of medical devices
Our instrumental analytics methods
- Atomic absorption spectrometry (AAS) using the following techniques: flame, nitrous oxide, graphite furnace, hydride and the corresponding digestion methods: acid digestion and microwave digestion to detect metals
- Inductively coupled plasma mass spectrometry (ICP-MS) for trace analysis of heavy metals such as mercury, lead or cadmium
- Gas chromatography (GC) with the following detectors: FID, NPD and MSD, e.g. determination of content and purity of pharmaceutical raw materials and finished products, residual solvents, fatty acid composition