Messer Production - Carbon Dioxide Refrigerated Liquid Usp

Messer Production - Carbon Dioxide Refrigerated Liquid Usp
SPL v16
SPL
SPL Set ID c1cba94b-7550-a95e-13ab-3c09aedde81a
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-11-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbon Dioxide (990 mL)

Identifiers & Packaging

Marketing Status
NDA Active Since 1965-01-01

Description

Bulk Carbon Dioxide USP Certificate of Analysis This is to certify that the carbon dioxide tested at MESSER PLANT on 10/27/2025, meets the United States Pharmacopoeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use. NDA 205815 NADA 141371 Furthermore, batch number 5784-A-102725-01, and lot number TCO2002-102725-13, which was loaded on 10/27/2025 and produced at MESSER PLANT comprises this shipment and was analyzed as shown below. Analytical results are generated using USP monograph or validated equivalent methods. FOR MEDICAL USE Requirement Analytical Method Limit of Detection¹ Specification Limit Result Carbon Dioxide Assay (CO₂) Speed of Sound 99.99% 99.0% 99.99% Nitrogen Oxide (NO) IMR-MS 0.05 ppm 2.5 ppm ND Nitrogen Dioxide (NO₂) IMR-MS 0.1 ppm 2.5 ppm ND Ammonia (NH₃) IMR-MS 0.03 ppm 25 ppm ND Sulfur Dioxide (SO₂) IMR-MS 0.03 ppm 5 ppm ND Hydrogen Sulfide (H₂S) IMR-MS 0.03 ppm 1 ppm ND Carbon Monoxide (CO) FTIR 0.05 ppm 10 ppm ND Moisture (H₂O) Quartz Crystal 0.5 ppm 200 ppm 0.77 ppm Notes: Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification. The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND. ND = None Detected ppm = parts per million by volume, ppb = parts per billion by volume, 1 ppm = 1,000 ppb Product analyzed using Messer Ultra Guard Suite Certified By:   On: (Signature)              (Date) John Doe (Print Name & Title) On behalf of Messer


Medication Information

Description

Bulk Carbon Dioxide USP Certificate of Analysis This is to certify that the carbon dioxide tested at MESSER PLANT on 10/27/2025, meets the United States Pharmacopoeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use. NDA 205815 NADA 141371 Furthermore, batch number 5784-A-102725-01, and lot number TCO2002-102725-13, which was loaded on 10/27/2025 and produced at MESSER PLANT comprises this shipment and was analyzed as shown below. Analytical results are generated using USP monograph or validated equivalent methods. FOR MEDICAL USE Requirement Analytical Method Limit of Detection¹ Specification Limit Result Carbon Dioxide Assay (CO₂) Speed of Sound 99.99% 99.0% 99.99% Nitrogen Oxide (NO) IMR-MS 0.05 ppm 2.5 ppm ND Nitrogen Dioxide (NO₂) IMR-MS 0.1 ppm 2.5 ppm ND Ammonia (NH₃) IMR-MS 0.03 ppm 25 ppm ND Sulfur Dioxide (SO₂) IMR-MS 0.03 ppm 5 ppm ND Hydrogen Sulfide (H₂S) IMR-MS 0.03 ppm 1 ppm ND Carbon Monoxide (CO) FTIR 0.05 ppm 10 ppm ND Moisture (H₂O) Quartz Crystal 0.5 ppm 200 ppm 0.77 ppm Notes: Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification. The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND. ND = None Detected ppm = parts per million by volume, ppb = parts per billion by volume, 1 ppm = 1,000 ppb Product analyzed using Messer Ultra Guard Suite Certified By:   On: (Signature)              (Date) John Doe (Print Name & Title) On behalf of Messer

Section 51945-4

Bulk Carbon Dioxide USP Certificate of Analysis

This is to certify that the carbon dioxide tested at MESSER PLANT on 10/27/2025, meets the United States Pharmacopoeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use. NDA 205815 NADA 141371

Furthermore, batch number 5784-A-102725-01, and lot number TCO2002-102725-13, which was loaded on 10/27/2025 and produced at MESSER PLANT comprises this shipment and was analyzed as shown below.

Analytical results are generated using USP monograph or validated equivalent methods.

FOR MEDICAL USE

Requirement

Analytical Method

Limit of Detection¹

Specification Limit

Result

Carbon Dioxide Assay (CO₂)

Speed of Sound

99.99%

99.0%

99.99%

Nitrogen Oxide (NO)

IMR-MS

0.05 ppm

2.5 ppm

ND

Nitrogen Dioxide (NO₂)

IMR-MS

0.1 ppm

2.5 ppm

ND

Ammonia (NH₃)

IMR-MS

0.03 ppm

25 ppm

ND

Sulfur Dioxide (SO₂)

IMR-MS

0.03 ppm

5 ppm

ND

Hydrogen Sulfide (H₂S)

IMR-MS

0.03 ppm

1 ppm

ND

Carbon Monoxide (CO)

FTIR

0.05 ppm

10 ppm

ND

Moisture (H₂O)

Quartz Crystal

0.5 ppm

200 ppm

0.77 ppm

Notes:

Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification.

The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND.

ND = None Detected

ppm = parts per million by volume, ppb = parts per billion by volume, 1 ppm = 1,000 ppb

Product analyzed using Messer Ultra Guard Suite

Certified By:

  On:

(Signature)              (Date)

John Doe

(Print Name & Title)

On behalf of Messer


Structured Label Content

Section 51945-4 (51945-4)

Bulk Carbon Dioxide USP Certificate of Analysis

This is to certify that the carbon dioxide tested at MESSER PLANT on 10/27/2025, meets the United States Pharmacopoeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use. NDA 205815 NADA 141371

Furthermore, batch number 5784-A-102725-01, and lot number TCO2002-102725-13, which was loaded on 10/27/2025 and produced at MESSER PLANT comprises this shipment and was analyzed as shown below.

Analytical results are generated using USP monograph or validated equivalent methods.

FOR MEDICAL USE

Requirement

Analytical Method

Limit of Detection¹

Specification Limit

Result

Carbon Dioxide Assay (CO₂)

Speed of Sound

99.99%

99.0%

99.99%

Nitrogen Oxide (NO)

IMR-MS

0.05 ppm

2.5 ppm

ND

Nitrogen Dioxide (NO₂)

IMR-MS

0.1 ppm

2.5 ppm

ND

Ammonia (NH₃)

IMR-MS

0.03 ppm

25 ppm

ND

Sulfur Dioxide (SO₂)

IMR-MS

0.03 ppm

5 ppm

ND

Hydrogen Sulfide (H₂S)

IMR-MS

0.03 ppm

1 ppm

ND

Carbon Monoxide (CO)

FTIR

0.05 ppm

10 ppm

ND

Moisture (H₂O)

Quartz Crystal

0.5 ppm

200 ppm

0.77 ppm

Notes:

Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification.

The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND.

ND = None Detected

ppm = parts per million by volume, ppb = parts per billion by volume, 1 ppm = 1,000 ppb

Product analyzed using Messer Ultra Guard Suite

Certified By:

  On:

(Signature)              (Date)

John Doe

(Print Name & Title)

On behalf of Messer


Advanced Ingredient Data


Raw Label Data

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