Messer Pr - Oxygen Usp Bulk Liquid -011

Messer Pr - Oxygen Usp Bulk Liquid -011
SPL v15
SPL
SPL Set ID 9cf7d65e-a69f-325e-f93a-d8c87d28173a
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-11-18
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (995 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 1960-01-01

Description

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


Medication Information

Description

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

Section 51945-4

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


Structured Label Content

Section 51945-4 (51945-4)

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


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Raw Label Data

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