Download Health Canada - Isomer Design

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Health Canada
Santé Canada
STATUS DECISION OF CONTROLLED
AND NON-CONTROLLED SUBSTANCE(S)
Substance: Despropionyl fentanyl
** SECONDARY REVIEW **
Based on the current information available to the Office of Controlled Substances, it appears that
the above substance is:
Controlled
X
Not Controlled
☐
under the schedules of the Controlled Drugs and Substances Act (CDSA) for the following
reason(s):

The substance is a metabolite of fentanyl and is captured under item 16(5) of Schedule I
to the CDSA.
Prepared by: _______________________________________
Vincent Marleau
Date: _______________
Verified by:
Date: ________________
_______________________________________
Mark Kozlowski
Approved by: _______________________________________
Date: ________________
DIRECTOR, OFFICE OF CONTROLLED SUBSTANCES
This status was requested by: Benoit Archambault, DAS
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Drug Status Report
Drug: Despropionyl fentanyl
Drug Name Status: Despropionyl fentanyl is the common name.
Chemical Name: 1-Phenethyl-N-phenylpiperidin-4-amine
Other Names: N-phenyl-1-(2-phenylethyl)-4-piperidinamine; N-phenyl-1-(2phenylethyl)piperidin-4-amine; 1-(beta-phenethyl)-4-anilinopiperidine; 4-anilino-Nphenethylpiperidine
Chemical structure:
Molecular Formula: C19H24N2
CAS-RN: 21409-26-7
Pharmacological class / Application: Fentanyl derivative
International status:
US: Despropionyl fentanyl is not listed specifically in the Schedules to the US Controlled
Substances Act and is not mentioned anywhere on the DEA website.
United Nations: The substance is not listed on the Yellow List - List of Narcotic Drugs under
International Control, the Green List - List of Psychotropic Substances under International
Control, nor the Red List - List of Precursors and Chemicals Frequently Used in the Illicit
Manufacture of Narcotic Drugs and Psychotropic Substances under International Control.
Canadian Status: Despropionyl fentanyl is not listed specifically in the Schedules to the CDSA.
The substance is a metabolite of fentanyl1, which is listed as sub-item 16(5) “Fentanyl (N–(1–
phenethyl–4–piperidyl) propionanilide)” in Schedule I to the CDSA under the heading
“Fentanyls, their salts, derivatives, and analogues and salts of derivatives and analogues,
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Clavijo, C.F. et al. (2011). A low blood volume LC-MS/MS assay for the quantification of fentanyl and its major
metabolites norfentanyl and despropionyl fentanyl in children. Journal of Separation Science: 34(24); 3568-3577.
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including:”. As a metabolite of fentanyl, Despropionyl fentanyl is captured by sub-item 16(5) in
Schedule I to the CDSA.
Recommendation: Despropionyl fentanyl is included in item 16(5) of Schedule I to the CDSA
and is a controlled substance.
Date: May 15th, 2013.