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

Due to profound regulatory changes the consideration of elemental impurities will be mandatory for all pharmaceutical products as of January 2018 at the latest. Multiwave PRO offers powerful options for sample preparation under full GMP compliance covering the huge variety of different drug formulations.

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 Finally after an intensive period of development the outdated wet chemical analysis is being replaced step by step by modern instrumental analysis in all relevant regulations.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 is going to become the future imperative for the specific quantification of elemental impurities.

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