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FDA Drug information

Carbon Dioxide

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20231005

Version

14

Spl Product Data Elements

Carbon Dioxide Carbon Dioxide Carbon Dioxide Carbon Dioxide Product Label

Application Number

NDA205815

Brand Name

Carbon Dioxide

Generic Name

Carbon Dioxide

Product Ndc

45149-014

Product Type

HUMAN PRESCRIPTION DRUG

Route

RESPIRATORY (INHALATION)

Package Label Principal Display Panel

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 (CO 2 ) Zahm Nagel 99.00% ≥ 99.0% Nitrogen Oxides (NOx) Detector Tube 0.5 ppm 2.5 ppm each Ammonia (NH 3 ) 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 (H 2 O) Analyzer 0.5 ppm 200 ppm or -33 ° F Dew Point

Package Label Principal Display Panel Table

RequirementTest MethodLimit of DetectionSpecification LimitAnalysis Results
Carbon Dioxide Assay (CO2)Zahm Nagel99.00%≥ 99.0%
Nitrogen Oxides (NOx)Detector Tube0.5 ppm2.5 ppm each
Ammonia (NH3)Detector Tube0.25 ppm25 ppm
Total SulfurAnalyzer10 ppb1000 ppb
Carbon Monoxide (CO)Detector Tube0.5 ppm10 ppm
Moisture (H2O)Analyzer0.5 ppm200 ppm or -33°F Dew Point

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