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Elemental-impurities-analysis - .PDF file.

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Finally after an intensive period of development the outdated wet chemical analysis has been replaced step by step by modern instrumental analysis in all relevant regulations.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

Anton Paar Ltd

Anton Paar develops, produces and distributes highly accurate laboratory instruments and process measuring systems, and provides custom-tailored automation and robotic solutions.

Anton Paar develops, produces and distributes highly accurate laboratory instruments and process measuring systems, and provides custom-tailored automation and robotic solutions.

It is the world leader in the measurement of density, concentration and CO2 and in the field of Rheometry. Other areas of specialty are: Viscometry, Polarimetry, Refractometry, Microwave Sample Preparation & Synthesis, Chemical and Mechanical Surface and Nanostructure Analysis.

With over 2200 employees at the headquarters in Graz (Austria) and the 25 sales subsidiaries worldwide, Anton Paar ensure that their products live up to their excellent reputation. The core competence of the company – high-precision production – and close contact to the scientific community form the basis for the quality of Anton Paar’s instruments.

A strong sales network in more than 110 countries guarantees customers rapid support and answers to their application and service queries.

Innovation is the basis for progress and every year Anton Paar invests more than 20 percent of the annual turnover in R&D.

Anton Paar Limited, a subsidiary of Anton Paar GmbH, provides sales, application support and service to users across the UK and Ireland.

With an office in St Albans (UK) and Dublin (Ireland) and a team of over 30 dedicated employees, Anton Paar Limited aims to provide first-class service at every stage in the customer relationship, ensuring our products live up to their excellent reputation.

Anton Paar Ltd
Unit F, The Courtyard
St Albans
AL4 0LA
UK

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