125742 S2 M3 32a3 excipient information structure alc 0315

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BNT162b2
3.2.A.3.1.2 Structure [ALC -0315]
PFIZER CONFIDENTIAL
Page 13.2.A.3.1.2. STRUCTURE [ALC -0315]
3.2.A.3.1.2.1. Chemical Structure
The AL C-0315 novel excipient is a cationic lipid containing a tertiary amine and two ester
moieties.  The chemical structure is shown in Figure 3.2.A.3.1.2-1.
Figure 3.2.A.3.1.2-1.Chemical Structure of ALC -0315
Asteri sks(*)indicate chiral centers .   
3.2.A.3.1.2.2. Molecular Formula
The molecular formula ofALC-0315 is C 48H95NO 5.  
3.2.A.3.1.2.3. Molecular Weight
The molecular weight ofALC-0315 is 766.27 Da ltons.   
3.2.A.3.1.2.4. Chirality
ALC-0315 has two chiral centers (indicated by  the * in Figure 3.2.A.3.1.2-1).  AL C-0315 is a 
1:1racemic mixture of two diastereomers. As such, AL C-0315 is not optically  active.
090177e19703618e\Approved\Approved On: 12-May-2021 07:35 (GMT)
FDA-CBER-2021-5683-1149038