A typical question in this area is the control of an active substance content or a test for impurities. Of course, the classic areas of raw material and product analysis or damage analysis are also of interest for medical technology products. This leads to the use of a wide range of analytical and physical methods:
Among the issues investigated are, for example, the composition and structure of membranes for filtration or dialysis. But medical textiles, reaction vessels, cannulae, contact lenses, bone substitutes and medical technology materials in general are also the subject of analysis in the field of medical technology.
Manufacturers of medical devices face special challenges. These include, for example, medical approvals, often at national level. The necessary tests are often required for new/modified products and the development of new markets. Analytik Service Obernburg also provides important advisory support in advance.
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The European Pharmacopoeia [Ph. Eur.] is a comprehensive collection of drug and raw material requirements (monographs), each with test methods to be performed. All medicines manufactured in Europe must comply agree to these standards. In addition, requirements are formulated for various medical devices. The fulfilment of these requirements is usually ensured by a combination of test methods.
We are pleased to support you in monitoring your raw materials, intermediate and/or final products according to various methods from the European Pharmacopoeia. Just contact us, ideally specifying the substance or product to be tested, and we will be glad to provide you with a customised offer.
Selection of methods currently to be carried out from Ph. Eur. 10 - depending on the analyte, if applicable:
2.2.5 Relative density
2.2.6 Refractive index
2.2.9 Capillary viscosimeter method
2.2.14 Melting point - capillary method
2.2.24 Absorption spectrophotometry, infrared (IR spectroscopy)
2.2.25 Absorption Spectrophotometry, Ultraviolet and visible (UV-Vis spectroscopy)
2.2.30 Size-exclusion chromatography (GPC / SEC)
2.2.32 Loss on drying
2.2.33 Nuclear magnetic resonance spectometry (NMR spectroscopy; in solution, 400 MHz)
2.2.34 Thermal analysis (thermogravimetry (TGA) and DSC (differential scanning calorimetry))
2.2.37 X-ray fluorescence spectrophotometry (XRF)
2.2.40 Near-infrared spectroscopy
2.2.42 Density of solids
2.2.44 Total organic carbon in water for pharmaceutical use (TOC)
2.2.48 Raman spectroscopy
2.2.57 Inductively coupled plasma-atomic emission spectrometry (ICP-OES)
2.9.31 Particle size analysis by laser diffraction (LPS)
2.9.37 Optical microscopy (LM)
2.9.52 Scanning electron microscopy (SEM-EDX)
Various titrations, e.g. reducing substances, alkalinity, acidity according to monographs
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