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Name:Nitrogen
Manufacturer:Aspen Air Us Corp
Category:Prescription Marketed Drugs


NITROGEN  - nitrogen gas 
Aspen Air US Corp

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NITROGEN CERTIFICATE OF ANALYSIS

THIS DOCUMENT IS THE CERTIFICATE OF ANALYSIS OF NITROGEN NF LOT # ______________________ SUPPLIED TO YOU IN A TRAILER FROM OUR BILLINGS MONTANA LOCATION OR PICKED UP BY THE CUSTOMER LISTED ABOVE IN THEIR TRAILER.  FOLLOWING THE ASPEN AIR MEDICAL GAS PROCEDURES OUR LOCATION ENSURES THAT THE OXYGEN USP PRODUCT IS MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS AND THE FDA'S MEDICAL GAS GUIDELINES.  THIS DOCUMENT IS INTENDED TO SERVE AS A CERTIFICATE OF ANALYSIS FOR THE OXYGEN USP WHEN THE RESULTS OF THE PRODUCT TESTING ARE ENTERED BELOW AND THE PRODUCT HAS BEEN DELIVERED TO A REGISTERED OXYGEN USP CUSTOMER.  THIS DOCUMENT IS IN COMPLIANCE WITH CURRENT FDA GUIDANCE

TEST                      SPECIFICATIONS                    RESULTS

ASSAY                    GREATER THAN 99.998%

IDENTIFICATION    NITROGEN

ODOR                        NONE

OXYGEN             LESS THAN 0.001%

CARBON MONOXIDE    LESS THAN 0.001%

THE METHODOLOGY USED FOR PERFORMING THE USP TEST FOR ASSAY AND IDENTIFICATION IS THE PARAMAGNETIC ANALYZER MODEL # TELEDYNE 2010 MA.  THIS ANALYZER HAS BEEN VALIDATED AS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP METHOD FOR OXYGEN ASSAY AND IDENTIFICATION.  THE VALIDATION STUDY IS AVAILABLE FOR REVIEW UPON REQUEST.  ODOR TESTING WAS PERFORMED BY THE OLFACTORY METHOD.  SUPPLIER SIGNATURE _________________________ DATE _________________

NUMBER 33 110 A1 - REVISION DATE 05/01/08

NITROGEN COA

GENERAL PRECAUTIONS

If this NITROGEN NF is not delivered to a properly registered
user the product is “Not approved for human drug use”.

This product has been produced by the air liquefaction
process and is exempt from these tests as stated in the USP / NF monograph for
NITROGEN

FOR ALL NITROGEN N INSTALLATIONS THE DRIVER SHALL ENSURE AND DOCUMENT THE FOLLOWING: HOSE CAPS (PLUGS) IN PLACE PRIOR TO DELIVERY YES/NO, GASKETS ARE SUITABLE FOR USE OR NEW YES/NO, HOSE PURGED PRIOR TO FILLING THE VESSEL YES/NO, HOSE RE-CAPED (PLUGGED) FOR STORAGE YES/NO.  DRIVER SIGNATURE:____________________ DATE:_________________


NITROGEN 
nitrogen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42914-010
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGEN (NITROGEN) NITROGEN 99 L  in 100 L
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42914-010-01 11000000 L in 1 TANK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 12/15/2007

Labeler - Aspen Air US Corp (790650449)
Registrant - Aspen Air US Corp (790650449)
Establishment
Name Address ID/FEI Operations
Aspen Air US Corp 790650449 manufacture

Revised: 01/2010 Aspen Air US Corp



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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