EUROPEAN PHARMACOPOEIA 11.5  – Cannabis flower

EUROPEAN PHARMACOPOEIA 11.5 – Cannabis flower

CANNABIS FLOWER
Cannabis flos

DEFINITION
Dried, whole or fragmented, fully developed female inflorescence of Cannabis sativa L. Content: if the herbal drug is to be prescribed to patients
as a medicinal product, the measured contents of total tetrahydrocannabinol and total cannabidiol, respectively, do not deviate from the values stated on the label by more than ± 10 per cent.

THC-dominant type:
– total tetrahydrocannabinol, expressed as Δ9-tetrahydrocannabinol (C21H30O2 ; Mr 314.5): minimum 5.0 per cent (dried drug);
– total cannabidiol, expressed as cannabidiol (C21H30O2 ; Mr 314.5): maximum 1.0 per cent (dried drug).

THC/CBD-intermediate type:
– total tetrahydrocannabinol, expressed as Δ9-tetrahydrocannabinol (C21H30O2 ; Mr 314.5): minimum 1.0 per cent (dried drug);
– total cannabidiol, expressed as cannabidiol (C21H30O2 ; Mr 314.5): minimum 1.0 per cent (dried drug);
– total tetrahydrocannabinol / total cannabidiol ratio: 0.2 to 5.0 (dried drug).

CBD-dominant type:
– total tetrahydrocannabinol, expressed as Δ9-tetrahydrocannabinol (C21H30O2 ; Mr 314.5): maximum 1.0 per cent (dried drug);
– total cannabidiol, expressed as cannabidiol (C21H30O2 ; Mr 314.5): minimum 5.0 per cent (dried drug).

 

Foreign matter (2.8.2): maximum 2 per cent ; if the herbal drug is to be prescribed to patients as a medicinal product, it does not contain any seeds and the whole herbal drug does not contain any leaves more than 1.0 cm in length.

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Manostaxx
Manostaxx – Industrial Management Consulting

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