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.
Posted by Dr. Tim Sandle