Messer Pr - Nitrogen Nf Bulk Liquid -016
a64bb3c9-3947-d2f3-a219-24b58ec41abc
34391-3
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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
Medication Information
Description
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
Section 51945-4
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
Structured Label Content
Section 51945-4 (51945-4)
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
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Source: dailymed · Ingested: 2026-02-15T11:50:21.211869 · Updated: 2026-03-14T22:37:11.582303