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European Pharmaceutical Review - Articles and news items

Caroline Richards

A few words from the editor of European Pharmaceutical Review

Blog / 12 April 2016 / Caroline Richards, Editor, European Pharmaceutical Review

Here, Caroline Richards, Editor of European Pharmaceutical Review, discusses the publication and the opportunities available to authors…

Towards Global stability protocols: a decade of lost opportunities

Issue 2 2013 / 18 April 2013 / European Pharmaceutical Review

This year marks the 10th anniversary of the introduction of the International Conference on Harmonisation (ICH) guidance on stability testing of new drug substances and products (ICH Q1A(R2)) and the ancillary guidance on storage conditions (ICH Q1F). In 2003, the pharmaceutical industry thought that it had achieved its goal of globally acceptable stability requirements, but unfortunately, that early optimism rapidly dissipated. Less than two years later, the ASEAN (Association of South East Asian Countries) group had broken ranks with ICH guidance and introduced their own guideline on stability requirements. In particular, they mandated the use of 30°C/75%RH for the long term storage conditions for climatic zone IV (hot and wet).

Under the MICROSCOPE with Volker J. Frost, Chief Profit Center Spectroscopy, Metrohm AG

Issue 2 2013 / 18 April 2013 /

Metrohm, a leading manufacturer of instruments for chemical analysis and FOSS, a leading supplier of dedicated analytical solutions to optimise quality and control, have entered into a strategic alliance strengthening the two companies’ leading positions in their respective key markets. In this strategic alliance, Metrohm will become the sole global distributor of FOSS NIR instruments for the chemical, petrochemical, pharmaceutical and environmental sectors. FOSS will continue its strong R&D program within NIR technology and manufacturing for both companies. Under the deal, FOSS NIRSystems, Inc., based in Laurel, Maryland, USA, will become a division of Metrohm USA to be named Metrohm NIRSystems. The global NIR instrument business for the abovementioned sectors will continue to be run by the Metrohm NIRSystems division of Metrohm.

 

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