The recently published (July 2022) 11th Edition of the European Pharmacopoeia (Ph. Eur.) includes the two revised harmonised monographs Paraffin, white soft (1799), and Paraffin, yellow soft (1554). The publication of these two texts marks an important step forward in the international harmonisation of excipient monographs conducted by the Pharmacopoeial Discussion Group (PDG) and is the successful outcome of several years of discussion between the Ph. Eur., the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) within the PDG and with other stakeholders.
The publication follows the approval of the sign-off documents by the PDG on 15 November 2021 (global text available on the web page “Harmonisation status for Excipient monographs (PDG)”).
Owing to the complexity of the topic and to differences in individual approaches and in regional regulatory requirements, considerable time and effort were invested in finding the best possible compromise. For example, the UV absorbance limit for polycyclic aromatic hydrocarbons has been significantly lowered to ensure it is compatible with regulatory requirements across all regions. The Consistency test has also been moved to the Functionality-related characteristics section as it is considered appropriate to assess the functionality of paraffin used as a basis in semi-solid preparations. The principal changes compared to the versions published in the 10th Edition of the Ph. Eur. are now also available in the Knowledge database of the European Directorate for the Quality of Medicines & HealthCare.
The revised versions of Paraffin, white soft (1799) and Paraffin, yellow soft (1554) will become legally binding on 1 January 2023. The JP and USP will publish their versions of the revised harmonised texts shortly.
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