NITROUS OXIDE by Praxair Mexico, S. de R.L. de C.V NITROUS OXIDE gas

NITROUS OXIDE by

Drug Labeling and Warnings

NITROUS OXIDE by is a Prescription medication manufactured, distributed, or labeled by Praxair Mexico, S. de R.L. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NITROUS OXIDE USP LABEL

PRAXAIR              Praxair Mexico S. de, R.L. de C.V.

                                Laboraicarlo de Costrel de Calidad de Producto

                                Plasia Toluca

                                Av Independence Ote No 300

                                CP 50070 Toluca Ede de Mexico

                                Tel          (722)2358800

Certificate of Analysis (COA)

Customer Name:              Praxair Distribution Inc.

Date:     March 23 th, 2018                            COA US 0928

Shipping Container:  63273

Product:                                               Nitrous Oxide USP Medical Gas

Pharmaceutical form:                    Medicinal gas    

Purity:                                                  99.0 cmol/ mol Min.       Expiration Date:               March 23 th, 2020

DUNS:                                                   8129539029                         FDA Establishment Identifier: 3012518051

Batch Number:                 TCM-N20-MED-002-18

This product described in this document meets the requirements of the United States Pharmacopeia 39th edition 2016, Mexican United States Pharmacopeia, 11th edition 2014, Praxair Mexico, S. de R.L. de C.V. and Praxair Distribution, Inc.

Component                        Specification                     Test Procedure                 Results

Nitrous Oxide Purity        Min. 99.0 cmol/moi         Gas Chromatograph        99.84 cmol/mol

Carbon Monoxide            Max. 5.0 µmol/mol          Detector tube                    < 5 µmol/mol

Carbon Dioxide                 Max. 300.0 µmol/mol     Detector tube                    < 300 µmol/mol

Nitric Oxide                        Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

Nitrogen Dioxide              Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

Ammonia                            Max. 25.0 µmol/mol       Detector tube                    < 25 µmol/mol

Halogens                                                                            

(Chlorine)                            Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

Moisture                             Max. 100.0 ppm               Detector tube                    < 100 ppm

Capacitance

Air                                          Max 1.0 cmol/mol            Gas Chromatograph        0.16 cmol/mol

Identity                                Positive                                Gas Chromatograph        Positive

La concentracion esto expresada en unidades del Sistoma Internaciona La unidad µmol/mol

Es equivalente a porm y cmol/ mol es equivalente a %mol/mol.

The concentration is expressed in units of the International System. The unit µmol/mol are equivalent to ppm and cmol/mol are equivalent to % mol/mol.

Compliance with requirements:                Yes _X_ No ___

                                                                                                                                Reviewer’s Signature:

                                                                                ____________________________________________

                                                                                                QI. MYRNA VEONICA CRUZ MARTINEZ

                                                                                                Quality Control Responsible.

IMPORTANT The information here contained it has been prepared by expert personnel of Praxair Mexico by way of orientation toward the user. The suggested analytic Techniques have demonstrated a high dependability I their results, however, the use that is given to the information it is completely user user’s exclusive responsibility. This report cannot be reportability. This report cannot be reproduced without authorization of the Laboratory of Coontrol of Quality of Product of Praxair Mexidom, S. de, R.L. de C.V., Toluca Plants.

QQ/r-08-019/1 – P0270

INGREDIENTS AND APPEARANCE

NITROUS OXIDE 
nitrous oxide gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72223-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029)	NITROUS OXIDE	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72223-001-01	7064200 L in 1 CONTAINER; Type 0: Not a Combination Product	06/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA210235	06/08/2017

Labeler - Praxair Mexico, S. de R.L. de C.V (812953909)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Mexico, S. de R.L. de C.V		812953909	manufacture(72223-001)