First published in the 1980s, the monographs on unfractionated heparin are some of the earliest texts of the European Pharmacopoeia (Ph. Eur.). Since then, significant effort has been expended by the Ph. Eur. experts to regularly revise these texts, with the most significant series of revisions performed following the heparin adulteration incidents in 2008.
The most recent draft versions of the texts have just been published in Pharmeuropa 34.3 (July 2022). The Production section in these proposed drafts has been amended to clarify statements on the control for absence of non-porcine source materials, an aspect that was already the subject of a public enquiry in 2021 (Pharmeuropa 33.3). In addition, it is proposed to lower the current limit for residual protein from ≤ 0.5 per cent to ≤ 0.1 per cent, a level considered more commensurate with a substance that is used in parenteral products.
The Ph. Eur. would like to encourage all stakeholders to provide feedback on the draft heparin monographs, in particular on the lowering of the limit for residual protein, via the Pharmeuropa platform by 30 September 2022 and invites them to submit relevant batch data together with approved specifications where issues are encountered with the proposed revision.