Pharmeuropa reviews

Pharmeuropa 28.1 contains two draft monographs of interest:

2.2.2    Degree of coloration of liquids

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

0333                Heparin Sodium

Related substances: the proposal is to introduce a disregard limit to the related substances test, in line with the principles of general chapter 2.2.46 Chromatographic separation techniques. The current text does not specify a quantitative limit for ‘any other impurity’ and compliance with the acceptance criterion depends on the sensitivity of the method.

Pharmeuropa 28.2 contains two further draft monographs of interest:

1473    Soya-bean oil, refined

Identification: reference to the test for composition of fatty acids has been added since it is more specific than that for identification of fatty oils by TLC; the latter has been maintained as second identification.

Composition of fatty acids: the term ‘and isomer’ has been included in the limit for oleic acid since baseline separation of oleic acid and its more abundant positional isomer, cis-vaccenic acid, is not achieved with the current method

2034                Substances for Pharmaceutical Use

In line with the implementation strategy of the ICH Q3D guideline, a new paragraph on elemental impurities has been added to this general monograph. Its aim is to clarify requirements for substances for pharmaceutical use used for the production of medicinal products that are outside of the scope of general chapter 5.20 (which will be aligned with the ICH Q3D guideline). For medicinal products within the scope of general chapter 5.20, the limits for elemental impurities apply to the medicinal product.

In addition, a sentence has been added to the production section to highlight the need during risk assessment, to take any necessary account of potential elemental impurities derived from intentionally added catalysts and reagents.

Pharmeuropa is an 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.

Posted by Dr. Tim Sandle