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Acellular pertussis vaccines: towards the replacement of the Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

EDQM 13/04/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is seeking public feedback on its proposal to replace the Histamine sensitisation test in mice (HIST) with a standardised CHO cell clustering assay for residual pertussis toxin testing, in general chapter 2.6.33 Residual pertussis toxin...

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Outcome of the 160th Session of the European Pharmacopoeia Commission

05/04/2018 Strasbourg, France

At its 160th Session which took place in Strasbourg on 20-21 March 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 19 new monographs, 3 new chapters, 51 revised monographs and 15 revised chapters.

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The Ph. Eur. revises its general chapter on Infrared Absorption Spectrophotometry

05/04/2018 Strasbourg, France

At its 160th session (March 2018) the Ph. Eur. Commission adopted a new version of one of its major general methods, which has undergone extensive revision. The chapter on Infrared Absorption Spectrophotometry (2.2.24) is one of the original cornerstones of pharmacopoeial testing, referenced...

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EDQM issues Automated Dose Dispensing (ADD) Guidelines

15/03/2018 Strasbourg, France

Many hospitals and pharmacies across Europe are becoming increasingly interested in automated dose dispensing (ADD) services. ADD is an automated process, which allows one or more medicinal products to be dispensed into a container/pouch for a patient to take at a particular date and time. The...

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EDQM rolls out reference standards for elemental impurities: lead, cadmium, mercury and arsenic

01/02/2018 Strasbourg, France

The European Directorate for the Quality of Medicines and Healthcare (EDQM) announces the availability of four new elemental impurity chemical reference standards (CRS) in its European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution...

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