125742 S34 M3 32a3 excipient information nomenclature alc 0315

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BNT162b2
3.2.A.3.1.1 Nomenclature [ALC -0315]
PFIZER CONFIDENTIAL
Page 13.2.A.3.1.1. NOMENCLATURE [ALC -0315]
Information on the nomenclature of AL C-0315 is provided in Table 3.2.A.3.1.1-1.  
Table 3.2.A.3.1.1-1. Nomenclature of ALC -0315
Nam e/code Description
Company or Laboratory Code ALC -0315 : ALC -315)
IUPAC Chemical Name [(4-Hydroxybutyl)azanediyl]di(hexane -6,1- diyl) bis(2-
hexyldecanoate)
Chemical Abstract Service Chemical 
NameDecanoic acid , 2-hexyl -, 1,1’ -[[(4-hydroxybutyl)imino]di -
6,1-hexanediyl] ester
Other Chemical Name (s) 6-[{6-[(2-Hexyldecanoyl)oxy]hexyl}(4 -
hydroxybutyl)amino]hexyl 2- hexyldecanoate
((4-hydroxybutyl)azanediyl)bis(hexane -6,1- diyl)bis(2 -
hexyldecanoate)
6-[N-6-(2-hexyldecanoyloxy)hexyl -N-(4-
hydroxybutyl)amino]hexyl 2 -hexyldecanoate
Chemical Abstract Service (registry 
number)2036272-55-4
090177e197bffe56\Approved\Approved On: 06-Aug-2021 14:38 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149499