EudraGMDP API reg: sukls334436/2021
Use: Active Pharmaceutical Ingredient for the manufacture of magistral formulas and for use in clinical trials
Origin: chemical synthesis
The individual tested parameters and limits are in accordance with the requirements of the German Drug Codex monograph (DAC/NRF 2020/2, C – 052), draft EDQM monograph (PA/PH/Exp. 11/T (21) 50 ANP) and general chapters of the European Pharmacopoeia (Ph. Eur.).
The product is manufactured, analysed, handled and stored in accordance with Good Manufacturing Practice (GMP) and as outlined in the International Conference on Harmonized „ICH Q7 guideline on Good Manufacturing Practice for Active Pharmaceutical Ingredients".
Stability data: ICH Zone II
Made in the EU.
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Identification & Functionality
Test specification: ASL/KJ/CBD-PhG-02
Quality criteria: DAC/NRF 2016/2, C-052
Applications & Uses
Properties
Value | Units | Test Method / Conditions | |
INN | Cannabidiolum | - | - |
IUPAC Name | 2-[(1R,6R)-3-methyl-6-prop-1-en-2-yl-1-cyclohex-2-enyl]-5-pentylbenzene-1,3-diol | - | - |
Solubility | Alcohols, Alkanes, Aromatic hydrocarbon, Chlorinated solvents, Polar aprotic solvents. | - | - |
Regulatory & Compliance
Packaging & Availability
Regional Availability
DUMA Special