previous few Carbon Dioxide Refrigerated Gas 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 (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 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) H 2 S, SO 2 , 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 CARBON DIOXIDE REFRIGERATED carbon dioxide gas Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52438-014 Route of Administration RESPIRATORY (INHALATION) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbon Dioxide (Carbon Dioxide) Carbon Dioxide 990 mL in 1 L Packaging # Item Code Package Description 1 NDC:52438-014-20 18770 L in 1 TANK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205764 01/01/1965 Labeler - Linde LLC (001368141) Registrant - Linde LLC (001368141) Establishment Name Address ID/FEI Operations Linde LLC 833150639 MANUFACTURE(52438-014), API MANUFACTURE(52438-014) Establishment Name Address ID/FEI Operations Linde LLC 020153345 MANUFACTURE(52438-014), API MANUFACTURE(52438-014) Revised: 10/2017 Linde LLC Print this page FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More from time to time
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