25 November 2020
The 11th edition of the Swiss Pharmacopoeia (Ph. Helv.) has been in force since 1 July 2012. On July 1, 2019, the third Supplement to it came into force.
Supplement 11.3 includes a new monograph on Cannabis Flowers in Ph. Helv. According to Swissmedic, the inclusion is based on the fact that there is a medical need to be able to prescribe cannabis flowers and preparations made from them with different THC-CBD ratios that differ from the currently authorized APIs. In consultation with the German Federal Institute for Drugs and Medical Devices (BfArM = Bundesinstitut für Arzneimittel und Medizinprodukte), the monograph on Cannabis Flowers of the German Pharmacopoeia (DAB = Deutsches Arzneibuch) was used as the basis for the new monograph. After practical testing by the Swissmedic laboratory OMCL, this monograph was optimized and adapted to the Swiss conditions.
The DAB monograph "Cannabis Flowers" was changed in 2018. For example, the run time of the HPLC assay method was shortened from 45 minutes to 20 minutes. The HPLC columns, the column temperature, the gradient and the run time now correspond to the method parameters given in Ph. Helv.
However, there are differences to the DAB monograph. For example, the limit value for loss on drying is max. 15% (DAB: max. 10%) and it is also determined differently (Ph. Helv.: drying in an oven at 105 °C for 2 h / DAB: drying in vacuum over a molecular sieve at 40 °C for 24 h). The assay by HPLC shows minor differences (e.g. sample preparation, injection volume).
The Ph. Helv. 11 is published by Swissmedic, the Swiss Agency for Therapeutic Products. The online version of Supplement 11.3 is available free of charge. Supplement 11.3 is cumulative and therefore contains all the texts of Supplements 11.1 and 11.2.