Carbon Dioxide Refrigerated Liquid: Package Insert / Prescribing Information - Drugs.com

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# Carbon Dioxide Refrigerated Liquid

Package insert / prescribing information
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 Messer Premier Guard Analysis suite
Analyst____________________________________________ Date: __________________________________
Reviewed and released by:____________________________ Date: __________________________________
_______________________________________________________________________
March 2019
CO2-22-06-RNA-Medical Gas USP Procedures
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Retention Period - 3 years

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 - Messer Merchant Production LLC (809567303)

Registrant - Messer Merchant Production LLC (831800201)

Establishment
Name | Address | ID/FEI | Operations
Messer Merchant Production LLC |  | 831800201 | manufacture(45149-014), api manufacture(45149-014)

Messer Merchant Production LLC

Medical Disclaimer