The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021).
The revision work focused on the osmolality reference solutions using sodium chloride that are required for instrument verification. New computation methods were applied to available scientific data to extend Table 2.2.35.-1. Preparation of osmolality solutions, which now describes a broader range of solutions with osmolality values up to 4000 mOsmol/kg. The new data model used also resulted in changes to the preparation of the historical solutions with osmolality values ranging from 100 to 700 mOsmol/kg. In addition, the group of experts in charge used the revision opportunity to overhaul the information given in this general chapter and bring it in line with the latest requirements.
All interested parties are encouraged to review the draft and submit their comments before the deadline of 31 December 2021.
For more information on how to comment, please consult our guide “How to comment”. Comments from states parties to the Ph. Eur. Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.
- European Pharmacopoeia 10th Edition
- European Pharmacopoeia Commission
- European Pharmacopoeia work programme
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