Label: CARBON DIOXIDE REFRIGERATED- carbon dioxide gas
- NDC Code(s): 52438-014-20
- Packager: Messer LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 2, 2021
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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
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: __________________________________
CO2-22-06-RNA-Medical Gas USP Procedures
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Retention Period - 3 years
INGREDIENTS AND APPEARANCE
CARBON DIOXIDE REFRIGERATED
carbon dioxide gas
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52438-014 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:52438-014-20 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 NDA205764 01/01/1965 Labeler - Messer LLC (001368141) Registrant - Messer LLC (001368141) Establishment Name Address ID/FEI Business Operations Messer LLC 833150639 manufacture(52438-014) , api manufacture(52438-014) Establishment Name Address ID/FEI Business Operations Messer LLC 020153345 manufacture(52438-014) , api manufacture(52438-014) Establishment Name Address ID/FEI Business Operations Messer LLC 004830011 manufacture(52438-014) , api manufacture(52438-014)