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

Due to profound regulatory changes the consideration of elemental impurities eventually is mandatory for all pharmaceutical products as of January 2018. Multiwave 7000 simultaneously enables the digestion of different sample matrices under full GMP compliance covering the huge variety of different drug formulations

1 Introduction

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.

1.1 Regulatory Background

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Finally after an intensive period of development the outdated wet chemical analysis has been replaced step by step by modern instrumental analysis in all relevant regulations.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.

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