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impurities test

Profound regulatory changes mean that the consideration of elemental impurities will be mandatory for all pharmaceutical products as of January 2018.

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.

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Finally, after an intensive period of development the outdated wet chemical analysis is being replaced step by step by modern instrumental analysis in all relevant regulations.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

Anton Paar conducted an experiment in order to demonstrate the excellent suitability of their instruments for sample preparation relating to elemental impurities analysis.

Three pharmaceutical products were analyzed: Painkilling Tablet, Dietary Supplement Capsule and Cold Syrup.

According to USP <233> the samples were spiked between 50 and 150 % of the target limit of each element. For evaluating these limits the respective PDE and the maximum daily dose stated on the package leaflet of the product were taken into consideration. The performance of the digestion was evaluated by calculating the recovery rates of the measured samples in relation to the theoretical values (unspiked sample + spiked value).

The focus was set on the “big four”, Cd, Pb, As and Hg, since they have the lowest PDE levels. Particularly As and Hg compounds are analytically demanding due to their volatile behaviour.

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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