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CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 1 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 24-May-2021 Specification: US EUA LIMIT LOT NUMBER: FC3184 ASSOCIATED LOT: EP8663, EY0563 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory agencies. Distribution to third parties without prior permission is prohibited. Form #: 01670 Revised: Oct 11 2010 TEST NAME TEST METHOD SPECIFICATION UNITS RESULT Appearance Appearance (Visual) White to off-white suspension None Meets Test Appearance (Visible Particulates)Appearance (Particles) May contain white to off- white opaque, amorphous particlesNone Meets Test Subvisible Particulate Matter - USP <787>particles/container Subvisible Particulate Matter - USP <787>particles/container Subvisible Particles Subvisible Particulate Matter - USP <787> None Meets Test pH 7.4 ± 0.5 None Osmolality Osmometry – USP <785>mOsmol/kg LNP Size Dynamic Light Scattering (DLS)nm LNP Polydispersity Dynamic Light Scattering (DLS)None RNA Content Fluorescence assay mg/mL RNA Encapsulation Fluorescence assay % ALC-0315 Content HPLC-CAD mg/mL ALC-0159 Content HPLC-CAD mg/mL DSPC Content HPLC-CAD mg/mL Cholesterol Content HPLC-CAD mg/mL Lipid Identities HPLC-CAD Retention times consistent with references (ALC-0315, ALC-0159, Cholesterol, DSPC)None Positive 090177e197848bc1\Approved\Approved On: 09-Jul-2021 03:27 (GMT) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149332 CERTIFICATE OF ANALYSIS PHARMACIA & UPJOHN COMPANYLLC (A SUBSIDIARY OF PFIZER INC) 7000 PORTAGE RD KALAMAZOO, MI 49001 -0199USAPage 2 of 2 Generated Date: 06-2021 Item: F000051489 Title: PFE-BNT 0.5MG/ML COVIDVX25X2ML GVL EUA Expiration Date: 31-Oct-2021 Date Of Manufacture: 24-May-2021 Specification: US EUA LIMIT LOT NUMBER: FC3184 ASSOCIATED LOT: EP8663, EY0563 Documentation is considered PROPRIETARY and is made available for business operations and review by employees and regulatory agencies. Distribution to third parties without prior permission is prohibited. Form #: 01670 Revised: Oct 11 2010 TEST NAME TEST METHOD SPECIFICATION UNITS RESULT Vial Content (Volume) Container content Not less than mL Identity of Encoded RNA SequenceRT-PCR Identity confirmed None Positive In Vitro Expression Cell-based Flow Cytometry% cells positive RNA Integrity Capillary Gel Electrophoresis% intact RNA Bacterial Endotoxins Endotoxin (LAL) EU/mL Sterility Sterility No growth detected None Meets Test All documentation has been reviewed and found to be in compliance with the Master Production Documents and applicable Quality Agreements. The product meets specifications and was manufactured, packaged and tested under GMP conditions according to current approved control procedures. 090177e197848bc1\Approved\Approved On: 09-Jul-2021 03:27 (GMT) (b) (4) (b) (4) (b) (4) (b) (4) (b) (6) (b) (6) FDA-CBER-2021-5683-1149333