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Carbon Dioxide (Linde Merchant Production Inc.)

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GAS 18770 L in 1 TANK (45149-014-01) Label Information

Complete Carbon Dioxide Information

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    CO2 USP CoA

    BULK CARBON DIOXIDE USP CERTIFICATE OF ANALYSIS

    This is to certify that the carbon dioxide produced at ______________________ on ______________________ meets the United States Pharmacopeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use.


    Furthermore, batch number ______________________ and lot number ______________________, which was loaded on ______________________and filled at ______________________, comprises this shipment and was analyzed as shown below.


    Analytical results are generated using USP monograph or validated equivalent methods.

    Requirement Test Method Limit of Detection Specification Limit Analysis Results
    Carbon Dioxide Assay (CO2) Zahm Nagel 99.00% ≥ 99.0%
    Nitrogen Oxides (NOx) Detector Tube 0.5 ppm 2.5 ppm each
    Ammonia (NH3) Detector Tube 0.25 ppm 25 ppm
    Total Sulfur Analyzer 10 ppb 1000 ppb
    Carbon Monoxide (CO) Detector Tube 0.5 ppm 10 ppm
    Moisture (H2O) Analyzer 0.5 ppm 200 ppm or -33°F Dew Point

    Note:
    1) Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification.
    2) The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND.
    3) ND=None Detected
    4)ppm= parts per million by volume, ppb=parts per billion by volume, 1ppm=1,000 ppb
    5) H2S, SO2, and other sulfur species are included in the total sulfur amount

    Product analyzed using Linde Premier Guard Analysis suite


    Analyst____________________________________________  Date: __________________________________



    Reviewed and released by:____________________________  Date: __________________________________



    _______________________________________________________________________

    6.0 September 2017
    CO2-22-06-RNA-Medical Gas USP Procedures
    Page 1 of 1
    Retention Period - 3 years
    Copyright © The Linde Group - Distributed by a locally registered Linde company


  • INGREDIENTS AND APPEARANCE
    CARBON DIOXIDE  
    carbon dioxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45149-014
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Carbon Dioxide (UNII: 142M471B3J) (Carbon Dioxide - UNII:142M471B3J) Carbon Dioxide 990 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45149-014-01 18770 L in 1 TANK; Type 0: Not a Combination Product 01/01/1965
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA205815 01/01/1965
    Labeler - Linde Merchant Production LLC (809567303)
    Registrant - Linde Merchant Production LLC (831800201)
    Establishment
    Name Address ID/FEI Business Operations
    Linde Merchant Production LLC 831800201 manufacture(45149-014) , api manufacture(45149-014)