البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)
Air Liquide Large Industries U.S. LP
NITROGEN
NITROGEN 99 L in 100 L
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
New Drug Application
NITROGEN - NITROGEN GAS AIR LIQUIDE LARGE INDUSTRIES U.S. LP ---------- NITROGEN NF BULK LIQUID NITROGEN N.F. COA AIR LIQUIDE NITROGEN N.F. Form Number: 2A-ALL-QUA-0003-F Revision: 0 Effective Date: 03/02/06 Page: 1/1 CERTIFICATE OF ANALYSIS Air Liquide large Industries U.S. L.P. – Houston, TX 77056 PRODUCED BY AIR LIQUEFACTION 1.Location Street Address1 2. Carrier ________________ Street Address 2 City, State Zip 3. Lot Number ______________________ 4. Trailer No _____________ PRE-FILL REPORT FILL REPORT 5.Residual Assay 6. Odor 7. Trailer loaded with appropriate product per appropriate (≤10 ppm O ) Detected loading procedure by: _______ ppm Yes No Signature _________________________ ________ ________ Date _____________________________ Initial Initial ANALYSIS REPORT Test required Method of Analysis Specifications Results ASSAY AND 8.PARAMAGNETIC ___ 99.998% N Minimum* 10. ____% IDENTIFICATION MICROFUEL CELL ___ ELECTROCHEMICAL ___ CELL 10 ppm O Maximum 11. _____ppm 9.Analyzer Tag Number 12.DETECTPR TUBE ___ 10 ppm CO Maximum 2 2 2 12.DETECTPR TUBE ___ 10 ppm CO Maximum 14. _____ppm CARBON INFARED ANALYZER ___ Expiration Date of Tube 15. ______ MONOXIDE Lot Number of Tube 16. ______ 13. Analyzer Tag Number ODOR Organoleptic (Nasal) None 17. ______ N.F. APPLIES ONLY WHEN USED IN A MEDICAL APPLICATION OR BY MEDICAL CUSTOMERS PROPERLY REGISTERED WITH THE FDA. * Plus inerts 18. Analyzed By ________________________ Date ____________ 19. Does this lot require additional testing? ___ NO ___ YES – attach page 2 20. SQCU Review/Release _______________________ Date ____________ MANDATORY FORM User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy. NITROGEN nitrogen gas PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:11853-023 ROUTE OF ADMINISTRATION RESPIRATORY (INHALATION) ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH NITROGEN (UNII: N762921K75) (NITROGEN - U اقرأ الوثيقة كاملة