Certificate of Analysis – Oxygen, USP
Customer Vendor / Supplier
This letter is to provide you with the Certification you requested for Oxygen, USP, Lot #,
supplied to you in cylinders / vessels by our location.
These cylinders were filled in accordance with the Standard Operating Procedures 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
USP Specification
Lot Analysis
Identification
Pass
Odor
No appreciable odor
Carbon Dioxide
< 0.03 %
*
Carbon Monoxide
≤ 0.001 %
*
Assay
> 99.0 %
NOTE: The USP/NF exempts facilities that manufacture Oxygen, USP by the Air Liquefaction process
from the tests for Carbon Dioxide and Carbon Monoxide. As our label states, our Oxygen, USP
is manufactured by the Air Liquefaction Process.
The methodology being used to perform the USP / NF Test for Assay is indicated below:
Paramagnetic Analyzer Model #
This method is an acceptable alternative to the official USP Orsat Method for Oxygen Assay.
Orsat
Official USP / NF method.
Supplier Signature Date
