Nitrogen

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 MED-09-05-USA-EN-ATT-04-Example Certificate of Analysis - Nitrogen NF

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.” nitrogen pr 2025