Registration Dossier

Identification

Chemical structure
Display Name:
Buprenorphine
EC Number:
257-950-6
EC Name:
Buprenorphine
CAS Number:
52485-79-7
Molecular formula:
C29H41NO4
IUPAC Name:
(1S,2R,6S,14R,15S,16R)-3-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-3-azahexacyclo[13.2.2.1^{2,8}.0^{1,6}.0^{6,14}.0^{7,12}]icosa-7,9,11-trien-11-ol

Type of substance

Composition:
mono-constituent substance
Origin:
organic

Total tonnage band

Total range:
Intermediate Use Only

REACH

Registered as:
INTERMEDIATE
Submitted:
Individual Submission

Publication dates

First published:
03-Feb-2016
Last modified:
13-Nov-2018

Chemical safety assessment

Performed for this substance:
NO

Compositions open all close all

Type:
legal entity composition of the substance
State Form:
solid: particulate/powder
Degree of purity:
> 98 - <= 100 % (w/w)


Constituent 1
Chemical structure
Reference substance name:
Buprenorphine
EC Number:
257-950-6
EC Name:
Buprenorphine
CAS Number:
52485-79-7
Molecular formula:
C29H41NO4
IUPAC Name:
(1S,2R,6S,14R,15S,16R)-3-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-3-azahexacyclo[13.2.2.1^{2,8}.0^{1,6}.0^{6,14}.0^{7,12}]icosa-7,9,11-trien-11-ol
Impurity 1
Chemical structure
Reference substance name:
(2S)-2-(4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl)-3,3-dimethylbutan-2-ol
CAS Number:
78715-23-8
Molecular formula:
C25H35NO4
IUPAC Name:
(2S)-2-(4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl)-3,3-dimethylbutan-2-ol
Impurity 2
Reference substance name:
Unknown impurity
IUPAC Name:
Unknown impurity
Impurity 3
Chemical structure
Reference substance name:
Dichloromethane
EC Number:
200-838-9
EC Name:
Dichloromethane
CAS Number:
75-09-2
Molecular formula:
CH2Cl2
IUPAC Name:
dichloromethane
Impurity 4
Reference substance name:
Unknow impurity
IUPAC Name:
Unknow impurity

Registrants /Suppliers of the substance open all close all

Latest dossier received
Registrant / Supplier details 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Indivior UK Ltd Henry Boot Way HU4 7DY Hull United Kingdom X

Administrative data open all close all

  • 01-2120105301-80-0000

Contact Persons responsible for the SDS