CARBON DIOXIDE REFRIGERATED- carbon dioxide gas

Carbon Dioxide Refrigerated by

Drug Labeling and Warnings

Carbon Dioxide Refrigerated by is a Prescription medication manufactured, distributed, or labeled by Messer LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
Page 1 of 1
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)