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

• 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