Revision of the Ph. Eur. Monograph Hop Strobile

Recommendation
12/13 November 2025
How to implement EU-GMP Chapter 8
Hop is commonly known for its use in brewing beer. However, it is also used as a herbal drug. Like Cannabis, it belongs to the hemp family (Cannabaceae). The Ph. Eur. Monograph Hop Strobile has now been proposed for revision in Pharmeuropa 35.2. The deadline for comments is 30 June 2023.
Proposed Changes
In the current Ph. Eur. Monograph, hop strobiles are defined as the dried, generally whole, female inflorescence of Humulus lupulus L. The revision intends to delete the "Characters" section as odour is "not highly characteristic and cannot be described with reference to the odour of a single compound". In addition, it is proposed to change the requirements for Foreign matter. Based on batch data received and the harvesting techniques used, the following separate limits for foreign organs and foreign elements have been introduced:
- Max. 6 % of foreign organs (i.e.,matter coming from the source plant but not defined as the herbal drug)
- Max. 2 % of foreign elements (i.e., matter not coming from the source plant and of either vegetable or mineral origin)
Other foreign elements as defined in Ph. Eur. 2.8.2 Foreign Matter are not covered by the limits. They should, as far as possible, be absent.
More information is available online in the draft Ph. Eur. Monograph Hop Strobile after registration (for free) to Pharmeuropa.
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