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Residual solvents in pharmaceutical products

Both finished pharmaceutical products and raw materials can contain residual solvents. In many cases, these originate from manufacturing and processing processes, where they were used in the synthesis or subsequent cleaning of products, but without being able to be completely eliminated.

The European (Ph. Eur.) and the US (USP) pharmacopoeias deal with the topic of solvent residues in the respective chapter on “Residual Solvents” (Ph. Eur. Chapter 5.4., USP Chapter <467>).

In 2008, new directives came into force, stipulating that it is no longer sufficient to test for residual solvents in accordance with the monograph of the respective raw material, but that tests have to be conducted for all solvents which could be contained in a substance or product.

These new directives have resulted in raising the requirements for analytical procedures regarding the determination of residual solvents.

In his article “Residual Solvents in Pharmaceutical Products”, Chemische Rundschau 5/2010, Stephan Manz, Deputy Head Chromatography Pharma, describes the procedures for the determination of residual solvents on the basis of the large number of matrices and analytes as well as in respect of current legislation.

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Restlösemittel: Bestimmung am Gaschromatographen
Residual solvents: determination on gas chromatographs
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