Thursday, 31 July 2014

Pharmeuropa 26.3 – items of interest

Pharmeuropa reviews are circulated for information. 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 (or supplement). The monograph is published about 6 months after adoption. Therefore draft text appearing in Pharmeuropa may not become official for up to 2 years. Those monograph’s adopted will be highlighted in reviews of the European Pharmacopoeia or supplements

Note: Pharmeuropa, Pharmeuropa Bio and Pharmeuropa Scientific Notes are available on line via EDQM web site.

Draft Monographs and General Texts for Comment:

5.3       Statistical Analysis of Results of Biological Assays and Tests

Equivalence testing. It is proposed to include an explicit mention of ‘equivalence testing’ in section 7.6. It is already noted in the introduction that the general chapter is not mandatory, and that methods that are not described but are supported by data and agreed by the competent authorities can be used. Nevertheless, ‘equivalence testing’ is now explicitly mentioned, which may facilitate consideration of this method by the competent authorities if it is presented with appropriate supporting documentation.

2.2.3    Potentiometric Determination of pH

The main changes in the revised text concern the choice of buffers used for the calibration of the pH meter which is now more flexible and does not start obligatorily with an initial calibration at pH 4.0. Furthermore, the chapter now allows the use of commercially available, certified reference materials as buffer solutions.

Posted by Tim Sandle