German Pharmacopoeia Draft Monograph for Cannabis Extracts

A draft for a new DAB (Deutsches Arzneibuch = German Pharmacopoeia ) monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" has been published in the (German) Bundesanzeiger on Monday, May 6, 2019 (BAnz AT 06.05.2019 B6).

The definition of the monograph states that the cannabis extract is "the extract produced and adjusted from the whole or fragmented, flowering, dried shoot tips of the female plants of Cannabis sativa L. (Cannabaceae)"*.

Content

The content is defined as

• ∆9-Tetrahydrocannabinol (THC): minimum 1 % and maximum 25 % (m/m) for the extract and 90 to 110 % of the nominal content indicated on the label,
• Cannabidiol (CBD): maximum 10 % (m/m) for the extract and 90 to 110 % of the nominal content indicated on the label.

The assay and the tests are carried out by liquid chromatography (Ph. Eur. 2.2.29). Identification is carried out by high performance thin layer chromatography (Ph. Eur. 2.8.25). The maximum water content (Ph. Eur. 2.5.12) is 0,5 %.

Manufacturing

The extract is produced by a suitable extraction process such as heptane, ethanol or CO₂ extraction. The crude extract obtained is refined if necessary, dissolved in a suitable fatty oil such as medium-chain triglycerides, grape seed oil or similar, and thus adjusted to the specified content. The cannabinoid acids are decarboxylated appropriately during production.

Storage

The extract should be stored tightly closed, protected from light and at 2 to 8 °C. The label states the content of THC and CBD. Stabilizers have to be indicated by type and quantity.

Comments concerning the draft for the German Pharmacopoeia must be submitted to the Pharmacopoeia Commissions´ Office (Geschäftsstelle der Arzneibuch-Kommissionen) at the BfArM (German Federal Institute for Drugs and Medical Devices) by 1 July 2019 at the latest.

*Please note that these are not official translations