Thursday, 14 January 2016

Pharmeuropa 27.4


A new edition of Pharmeuropa has been issued (October 2015), with the deadline for comments 31 December 2015.

Pharmeuropa is a free online EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months.

Draft Monographs and General Texts for Comment

2.2.38  Conductivity

This draft corresponds to Stage 4 within the Pharmacopoeial harmonisation process (Ph. Eur., JP, and USP). The coordinating pharmacopoeia is the USP.
A general revision of the text is proposed

2.2.1   Clarity and Degree of Opalescence of Liquids

General revision to restructure the text and eliminate unnecessary repetition. Based on comments from users and manufacturers, the requirements for accuracy and repeatability of the instrument have been changed

4.2.1    Primary Standards for Volumetric Solutions

Sodium carbonate has been replaced by trometamol and a new primary standard has been introduced to allow more single-step standardisations. Additional recommendations for the use of primary standards have been added

4.2.2    Volumetric Solutions

General revision in order to introduce more single-step standardisations using a primary standard. Use of potentiometric end-point determination has also been emphasised and the conditions for the use of commercial solutions have been changed.3Wherever possible, toxic reagents have been replaced

Glossary (1502)

Basis: the definition has been reworded, including the notion of single-phase and multiphase systems.
Colloidal dispersion, Emulsion, Suspension: it has been decided to include under the term ‘dispersion’ the definition of colloidal dispersion, emulsion and suspension, and to revise each of these definitions.
Solution: some additional information on the state of the dissolved substances has been included.
Standard Term: a more detailed definition has been elaborated.

Posted by Dr. Tim Sandle