The Pharmacopoeial Discussion Group (PDG)¹ works to harmonise the technical content of selected excipient monographs and general chapters (more information here). An important step forward in the harmonisation effort has been achieved recently for a number of texts.
Numerous texts have been signed off since the PDG October 2022 meeting (see details in the press release and related meeting highlights) and are now available on the Pharmacopoeial Harmonisation section of the EDQM website. These include:
- a new text on Particle Size Analysis by Dynamic Light Scattering (G-21),
- a revision of the general chapters Bulk Density of Powders (G-02) and Powder Flow (G-05),
- a number of corrected texts and modified excipient monograph sign-off cover sheets.
The corresponding revised Ph. Eur. texts are scheduled to be published in Supplements 11.4 and 11.5.
Two revised and harmonised texts, general chapter 2.9.1. Disintegration of tablets and capsules and the monograph on Maize starch (0344), have been published in Pharmeuropa 35.2 for public consultation.
The first of these, Ph. Eur. 2.9.1. Disintegration of tablets and capsules, has been revised to include Test B for dosage forms larger than 18 mm in the harmonised part of the text. While the apparatus described in Test B and its operation have been described in the general chapter for some time, the section on Test B was – until this latest revision – listed as a Ph. Eur. local requirement. With this change, the PDG has reached another milestone in the harmonisation efforts for disintegration tests.
Maize starch (0344) has been revised to modify the description of the starch granules given in Identification A (microscopic examination). The size limits for the diameters of both angular polyhedral granules and rounded/spheroidal granules have been revised to a uniform maximum of about 35 µm, based on stakeholder feedback and testing of material from several manufacturers.
The revised texts remain open for public consultation until 30 June 2023. All interested parties are encouraged to review the drafts and submit their comments. For more information on how to comment, please consult our guide.
Both texts will also soon be published for public consultation by the JP and USP in their respective fora. Comments will be discussed by the relevant groups of experts and within the PDG before aligning the revised sign-off texts.
Stakeholder collaboration is fundamental throughout the process of elaboration and revision of pharmacopoeial texts. We encourage users to regularly check Pharmeuropa for new texts published for public consultation.
Further texts undergoing pharmacopoeial harmonisation within the PDG are being prepared for publication by 1 July 2023 in Pharmeuropa 35.3 (currently scheduled are Capillary electrophoresis (2.2.47) and Sodium calcium edetate (0231)).