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Carbon Dioxide Refrigerated Liquid

Dosage Form: gas

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CARBON DIOXIDE  
carbon dioxide gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45149-014
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbon Dioxide (Carbon Dioxide) Carbon Dioxide 990 mL  in 1 L
Packaging
# Item Code Package Description
1 NDC:45149-014-01 18770 L in 1 TANK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205815 01/01/1965
Labeler - Linde Merchant Production Inc. (809567303)
Registrant - Linde Merchant Production Inc. (831800201)
Establishment
Name Address ID/FEI Operations
Linde Merchant Production Inc. 831800201 MANUFACTURE(45149-014), API MANUFACTURE(45149-014)
Revised: 10/2017
 
Linde Merchant Production Inc.
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