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Oxygen

Linde Canada LTD

Oxygen USP Bulk Liquid


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 

Linde

Certicate of Analysis - Oxygen USP

Product: Oxygen USP

Date

 

Facility Name

 

Facility Address

 

Lot#

 

Batch #

 

Final Analysis Results

Analyzer #

Test/Units

USP Specs

Analysis Results

N/A

Odor

None

 

 

% O2

> 99.0%
(Linde Spec >99.50%)

  %

 

ppm H2O

N/A

  ppm

 

ppm THC

N/A

  ppm

N/A

% CO

less than or equal to .001

  ***

N/A

% CO2

less than or equal to .03

  ***

NT= not tested

*** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.

The methodology used to perform the USP test:

     Paramagnetic Analyzer Manufacturer / Model# : _______________________________________________

This analyzer has been validated by Linde as acceptable alternatives to the official USP for Oxygen 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 USP 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

Oxygen

Oxygen GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52003-011
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxygen Oxygen 995 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52003-011-20 18144 in 1 TANK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205817 1960-01-01


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