125742 S2 M3 32p52 analytical procedure endotoxin

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BNT162b2
3.2.P.5.2 Analytical Procedures 
Endotoxin
PFIZER CONFIDENTIAL
Page 13.2.P.5.2. ENDOTOXIN
Endotoxin testing for BNT162b2 drug product is performed using a  
limulus amebocy te lysate (LAL) anal ytical procedure in accordance with USP <85> , Ph. Eur. 
2.6.14 and JP 4.01. 
090177e19700b009\Approved\Approved On: 12-May-2021 07:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149274