125742 S2 M3 32p52 analytical procedure osmometry

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BNT162b2
3.2.P.5.2 Analytical Procedures
Osmometry
PFIZER CONFIDENTIAL
Page 13.2.P.5.2. OSMO METRY
The anal ytical procedure for measuring the osmolality  of the BNT162b2 drug product is 
performed using freezing point depression in accordance with USP <785>. The method is 
also performed in accordance with Ph .Eur.2.2.35 with slight differences in instrument 
calibration.
090177e195d53594\Approved\Approved On: 18-Dec-2020 07:11 (GMT)
FDA-CBER-2021-5683-1149275