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Effiziente Bestimmung von Lösemittelresten in Wirkstoffen und Zwischenprodukten unter rationellen GMP-Bedingungen

Stephan Weigel, Torsten Freyholdt und Stephan Küppers Schering AG, Inprozess-Analytik, Berlin

Efficient Determination of Residual Solvents in Drug Products and Intermediates under Rational GMP Conditions

In pharmaceutical industry processes comply with current good manufacturing practice (cGMP) today. Unfortunately compliance programs often lead to dramatic increase of paper work and loss of efficiency. Though compliance has to deal with more documentation, an organisation of the work-flow can lead to efficient procedures that comply with cGMP and combine compliance with a minimum of analysis costs. This paper demonstrates an efficient procedure for the determination of residual solvents in drug products and intermediates, which complies with cGMP standards and the need for flexibility in an industry analysis laboratory in pharmaceutical industry.

Key words Bestimmung von Lösemittelresten · cGMP-Konformität · Effizienz · Minimierung der Durchlaufzeiten · Routinetauglichkeit