Animal NDC 52374-916-20 Nitrogen
Animal Product Information
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Nitrogen Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Package Label.Principal Display Panel
Certificate of Analysis – Nitrogen, NF
Customer Vendor / Supplier
This letter is to provide you with the Certification you requested for Nitrogen, NF, Lot #.
supplied to you in cylinders / vessels by our location.
These cylinders were filled in accordance with the Standard Operating Procedures utilized for the manufacture of
Medical Gases. By following these procedures, our location ensures that products are safely manufactured in
compliance with FDA’s Current Good Manufacturing Practices (cGMP) Regulations and FDA Medical Gas Guidelines.
CAUTION: Vendor supplies this certification to customer to assist customer in ensuring compliance with 21 CFR
211.84. This certification does not eliminate customer’s obligation to comply with other portions of 21 CFR 210 & 211
including but not limited to 21 CFR 211.265 (finished product testing) for cylinders and vessels filled from these supply
cylinders. These cylinders are not certified for instrument calibration purposes.
Test / Requirement
NF Specification
Lot Analysis
Identification
Pass
Odor
No appreciable odor
Oxygen
< 1.0 %
Carbon Monoxide
≤10 ppm
Assay
≥ 99.0 %
The methodology being used to perform the NF Test for Assay is indicated below:
Paramagnetic Analyzer Model #
Electrochemical Analyzer Model #
These analyzers have been validated as acceptable alternatives to the official NF Gas Chromatography
method for Nitrogen Assay. Validation study documentation is available.
Gas Chromatography
Official USP / NF method.
Supplier Signature Date
Certificate of Analysis – Nitrogen NF
Product:
Nitrogen NF
Date
Facility Name
Facility Address
Lot #
NDA
205816
Batch #
NADA 141372
Final Analysis Results
Analyzer #
Test / Units
NF Specs
Analysis Results
N/A
Odor
None
ppm O₂
≤ 10,000
ppm
(Messer Spec ≤5.0)
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%
%
(Messer Spec ≥99.999%)
NT = not tested
ppm O₂ Method Used: Manufacturer / Model #:
ppm CO Method Used: Manufacturer / Model #:
These analyzers have been validated by Messer as acceptable alternatives to the official NF for Nitrogen Assay.
Validation study documentation is maintained by Messer at the corporate offices.
Analyst
Date
Quality Reviewer
Date
Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
