NITROGEN- nitrogen gas

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)

Available from:

Air Liquide Large Industries U.S. LP

INN (International Name):

NITROGEN

Composition:

NITROGEN 99 L in 100 L

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

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