125742 S11 M3 32r 21y513c2401 coa

Pfizer Documents (PHMPT/FDA)

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Document text

Pharmaceutical Sciences
Worldwide Research & Development
Certificate of 
Analysis
Material Type:
Material Description or 
Name:
Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient
21Y513C2401
Authorized By
09-Feb-2021
REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T
Appearance (Clarity)
Clarity
Appearance (Coloration)
Coloration
pH
UV Spectroscopy
Content (RNA Concentration)
RT-PCR
Identity of Encoded RNA Sequence
Capillary Gel Electrophoresis
RNA Integrity
RP-HPLC
5-Cap
ddPCR
Poly (A) Tail
qPCR
Residual DNA Template
Immunoblot
dsRNA
Endotoxin (LAL)
Bacterial Endotoxins
Bioburden
Bioburden
Page 1 of 1 Pfizer Confidential Report Created: 08-Jul-2021
1066265 / Last Modified: 02-Apr-2021
090177e19783cb8f\Approved\Approved On: 08-Jul-2021 20:05 (GMT)
(b) (4)
(b) (4)
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FDA-CBER-2021-5683-1149324