Since elemental impurities constitute not only a toxicological risk for the patient but also may affect the quality and efficacy of pharmaceutical products, their analysis plays an important role within the development and quality control of pharmaceuticals.
Due to profound regulatory changes the consideration of elemental impurities is mandatory for all pharmaceutical products as of January 2018.
So far heavy metal analysis was performed by sulfidic precipitation according to a limit test stated in USP chapter <231> and Ph. Eur. 2.4.8. This more than 100 years old procedure is nonspecific and does not allow the determination of concrete quantitative results.
Finally after an intensive period of development the outdated wet chemical analysis has been replaced step by step by modern instrumental analysis in all relevant regulations.
Due to these changes the use of ICP-OES or ICP-MS together with reliable sample preparation techniques such as microwave-assisted closed vessel digestion has become the current imperative for the specific quantification of elemental impurities.
In order to demonstrate the excellent suitability of Multiwave 7000 microwave from Anton Paar for sample preparation relating to elemental impurities analysis, four pharmaceutical products (a painkilling tablet, cold syrup, nicotinic acid and a dietary supplement) were defined, covering a wide range of different formulations and show varying reaction behavior during the digestion:
Click on the link above to download this report and see the full details of this experiment and its interesting findings.
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