Helium gas

Ingredients and appearance - Product information

Helium gas- Helium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 52438-015
Route of Administration Respiratory (inhalation)

Active Ingredient/Active Moiety

Ingredient Name Strength
Helium ( UNII: 206GF3GB41)( Helium - UNII: 206GF3GB41 ) 990 mLin 1 L

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved medical gas USA

Labeler - Linde LLC( 001368141)

Package label.principal display panel

Helium label image

Helium USP Certificate of Analysis

Product:

Helium, USP

Date

Facility Name

Facility Address

Lot #

Batch #

Final Analysis Results

Analyzer #

Test / Units

USP Specs

Analysis Results

GC 1

% Helium Assay

> 99.0%

%

GC 1

% Air

< 1.0%

ppm N2

ppm O2

Drager Tube

ppm CO

< 10 ppm

ppm

N/A

Odor

None

N/A

Identification

Pass

NT = not tested The methodology used to perform the assay and air USP tests : 1 The assay and air determinations are performed using a Gow-Mac Gas Chromatograph Manufacturer Model: #590-1 or a Valco Gas Chromatograph Manufacturer Model: #5000

Analyst

Date

Quality Reviewer

Date

Should the material not be delivered to a USP customer, the material is Not Approved for Human Drug Use.
July 2010
Helium USP Certificate of Analysis
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