10/11 October 2023
A revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published in Pharmeuropa 35.3. The comment deadline is 30 September 2023.
A reference to the general Ph. Eur. chapter Contaminant pyrrolizidine alkaloids (2.8.26) has been added to make the useful guidance provided therein more visible. Pyrrolizidine alkaloids (PAs) are nitrogen-containing compounds that occur naturally in plants. According to the EDQM "several hundred structurally distinct PAs have been found in several thousand different plant species. Many of these plants are common weeds, which can contaminate raw plant materials used for the production of medicinal products". This may result in contamination by PAs of raw plant materials but also other natural products such as honey (usually at very low levels).
In addition, the wording "specific" monograph has been changed to "individual" monograph throughout the text.
Following your registration to Pharmeuropa online you will have access to the full Ph. Eur. draft for the general monograph Pharmaceutical Preparations.