Closed Vessel Digestion for Elemental Impurities Analysis of Osmium According to ICH Q3D, USP <232>, <233> and Ph. Eur. 5.20 with PDC

Using the Multiwave 7101/7301/7501 series simultaneously facilitates the digestion of different sample matrices under full GMP compliance and even generates digestion solutions enabling the accurate and reproducible determination of very difficult to determine Osmium.

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 new regulations in the United States Pharmacopoeia (USP <232> and <233>), the European Pharmacopoeia (Ph. Eur. 5.20) as well as the International Conference on Harmonization (ICH Q3D) the use of ICP-OES or ICP-MS together with reliable sample preparation techniques such as microwave-assisted closed vessel digestion has become state of the art for the quantification of elemental impurities.

Amongst other elements these regulations also define permitted daily exposure limits (PDE) for Osmium since the platinum element Os is known to be used as catalyst during the production chain of certain active pharmaceutical ingredients (APIs).

The digestion of the sample matrix mainly is done by oxidising mineral acids like HNO3 which will cause problems in the determination of Os traces, since this element forms different species of varying volatility under such conditions which again leads to uncontrolled losses of Os. Osmium tetroxide e.g. is not only highly volatile but also very toxic by inhalation, ingestion and skin contact.

This report applies Multiwave 7000 and after the digestion a dilution with a stabilization solution containing acetic acid, ascorbic acid and thiourea in order to stabilize Os in the oxidizing environment during the sample preparation of one pharmaceutical product and one API.

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