Monday, 21 April 2014

Pharmeuropa 26.2 (April 2014)

A new edition of Pharmeuropa has been issued. Pharmeuropa is a free online EDQM publication.Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months. Comments received are processed by EDQM, at this stage the draft can be amended and republished. If no further revision is required the draft monograph is proposed to the European Pharmacopoeia Commission if adopted an implementation date is given and this is about one year after the adoption of the monograph. The monograph is then published in the European Pharmacopoeia.

Items of interest in the current edition are:


2.6.15 Prekallikrein Activator

Additional clarification provided on spiking experiments and high blank values.

2.5.32  Water: Micro Determination

The main changes in the proposed revision are the following:

the recommendation to determine quantities of water greater than 100µg has been included;
a suitable certified reference material may be used for instrument performance verification;
increased flexibility for the frequency of the verification of accuracy

2.2.20  Potentiometric titration

General method updated to introduce modern autotitrator instruments. Based on EU regulation 847/2012, reference to mercury-containing electrodes have been deleted

Sodium Hydroxide (0677)

The current manufacturing process for producing sodium hydroxide that complies with the current monograph will be changed by 2016 for ecological reasons. Due to the new process, the concentrations of chlorides and sulfates in the substance will increase and will no longer comply with the current limits. It is proposed to anticipate this situation and expand the limits of the tests concerned as this has no impact on the quality of the substance.

Posted by Tim Sandle