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Nitrogen

Linde LLC
Linde LLC

Nitrogen NF Bulk Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

Linde

Certicate of Analysis - Nitrogen NF

Product: Nitrogen NF

Date

 

Facility Name

 

Facility Address

 

Lot#

 

Batch #

 

Final Analysis Results

Analyzer #

Test/Units

NF Specs

Analysis Results

N/A

Odor

None

 

 

ppm O2

< 10,000

(Linde Spec <5.0)

  ppm

 

ppm CO

< 10.0

  ppm

 

ppm THC

N/A

  ppm

 

ppm H2O

N/A

  ppm

 

ppm CO2

N/A

  ppm

 

ppm H2

N/A

  ppm

Assay Results

Nitrogen min %

> 99.0%

(Linde Spec >99.999%)

%

NT= not tested

ppm O2 method

Used:                  __________________________

Manufacturer/

Model #:                  __________________________

ppm CO method

Used:                  __________________________

Manufacturer/

Model #:                  __________________________

These analyzers have been validated by Linde as acceptable alternatives to the official NF for Nitrogen Assay.  Validation study documentation is maintained by Linde at the production location and 575 Mountain Avenue, Murray Hill, NJ  07974

Analyst

Date

 

 

 

 

Quality Reviewer

Date

 

 

 

 

 

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

2.3 October 2007

ASU-22-06-GAM-Medical Gas Procedures

Page 1 of 1

Retention Period – 3 Years

Copyright © The Linde Group – Distributed by a locally registered Linde Company

WARNINGS SECTION

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

Nitrogen

Nitrogen GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52438-016
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Nitrogen NITROGEN 995 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52438-016-20 25000 in 1 TANK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205766 1960-01-01


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