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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) (b) (6) FDA-CBER-2021-5683-1149324