FDA Label for Carbon Dioxide
View Indications, Usage & Precautions
Carbon Dioxide Product Label
The following document was submitted to the FDA by the labeler of this product Messer Merchant Production Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.