Carbon Dioxide Refrigerated Gas Prescribing Information
Package insert / product label 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
