COMPARISON OF EUROPEAN, US & JAPANESE PHARMACOPOEIA MONOGRAPHS FOR MEDICINAL GASES

Transcription

1 MEDICAL GASES MPARISON OF EUROPEAN, US & JAPANESE PHARMAPOEIA MONOGRAPHS FOR MEDICINAL GASES MGC Doc 152/11/E Revision of Doc 152/08 EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL AVENUE DES ARTS 3-5 B 1210 BRUSSELS Tel : Fax : info@eiga.eu Internet :

2 Doc 152/11 MPARISON OF EUROPEAN, US & JAPANESE PHARMAPOEIA MONOGRAPHS FOR MEDICINAL GASES PREPARED BY : Atoosa Bayat Peter Henrys Stefania Mariani Ichirou Nakayama Peter Neu Martin Schöfnagl François Simondet Francisco Revuelta Jan Strybol Andy Webb Linde Linde SOL JIMGA (Nippon Sanso Corp) Air Liquide Messer Group Air Liquide Praxair Air Products EIGA Disclaimer All technical publications of EIGA or under EIGA's name, including Codes of practice, Safety procedures and any other technical information contained in such publications were obtained from sources believed to be reliable and are based on technical information and experience currently available from members of EIGA and others at the date of their issuance. While EIGA recommends reference to or use of its publications by its members, such reference to or use of EIGA's publications by its members or third parties are purely voluntary and not binding. Therefore, EIGA or its members make no guarantee of the results and assume no liability or responsibility in connection with the reference to or use of information or suggestions contained in EIGA's publications. EIGA has no control whatsoever as regards, performance or non performance, misinterpretation, proper or improper use of any information or suggestions contained in EIGA's publications by any person or entity (including EIGA members) and EIGA expressly disclaims any liability in connection thereto. EIGA's publications are subject to periodic review and users are cautioned to obtain the latest edition. EIGA EIGA grants permission to reproduce this publication provided the Association is acknowledged as the source EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL Avenue des Arts 3-5 B 1210 Brussels Tel Fax info@eiga.eu Internet:

3 Table of Contents 1 Introduction Scope and purpose Scope Purpose Specifications and test methods European Pharmacopoeia test requirements Currency of Information Comparison tables Medical Oxygen % Oxygen Nitrous Oxide Nitrogen % Nitrogen Low Oxygen Nitrogen Carbon Dioxide Medicinal Air Synthetic Medicinal Air Helium Nitric Oxide Argon Carbon Monoxide Japanese Pharmacopoeia Medical Oxygen Nitrous Oxide Carbon Dioxide Nitrogen... 21

4 1 Introduction There are three prime regional Pharmacopoeia organisations that are responsible for the preparation and publication of Pharmacopoeia monographs, covering the commonly used substances involved in the manufacture and supply of medicinal products. The three prime organisations are: European Directorate for the Quality of Medicines (EDQM) - responsible for the European Pharmacopeia (Ph Eur) monographs United States Pharmacopeial Convention - responsible for the US Pharmacopoeia (USP) Ministry of Health and Welfare - responsible for the Japanese Pharmacopoeia (JP) The three Pharmacopoeias have monographs for a number of medical / medicinal gases. These gases can be used either as active ingredients in medicinal products or excipients, used in the manufacture of medical gas mixtures, administered to patients. Alternatively, they can be used as pharmaceutical gases, used in the manufacture, storage or distribution of all medicinal products. The purpose of these monographs is to specify for each gas: the minimum assay / purity for the product that is suitable for medicinal use the maximum level of defined impurities, that could have an adverse effect on the patient the appropriate test methods for determining quality of the product. This document provides a comparison between the specifications and the test methods defined in each of the regional pharmacopoeia compendiums. 2 Scope and purpose 2.1 Scope This document covers the pharmacopoeia monographs for medicinal and pharmaceutical gases published by the: European Pharmacopoeia (Ph Eur) United States Pharmacopeia (USP) Japanese Pharmacopoeia (JP) It includes the monographs for gases used in the manufacture and supply of medicinal products including: Medicinal gases, which are used as active ingredients in medical gases and gas mixtures supplied for patient use Excipient gases, which are added to gas mixtures but have no therapeutic effects Pharmaceutical gases, which are specified in the manufacture, storage and distribution of medicinal products. The comparison tables in the Appendix provide a comparison between the European and the United States Pharmacopoeia monographs for all of the specified gases. A separate table is included to detail the monographs published by the Japanese Pharmacopoeia, where the monographs do not specify acceptance limits and only provide test criteria for compliance. 2.2 Purpose The purpose of the document is to provide a simple cross reference between the three sets of published monographs to enable a comparison of the requirements for each method. This is intended to demonstrate compliance between monographs but should not be used as a detailed method of carrying out the relevant tests. Where the testing to a specific monograph is required, the user should refer to the original document (and all supporting documents within the relevant pharmacopoeia) to ensure that the tests are carried out correctly. 1

5 3 Specifications and test methods The most commonly used medicinal gases have been included in the Pharmacopoeia for many years but recently a number of new medical gases have been added. The following table gives a quick reference for the different gases that have been covered by published monographs in the three Pharmacopoeias: Gases European Pharmacopoeia Monograph Reference US Pharmacopoeia Japanese Pharmacopoeia Medical Oxygen No Reference No. Oxygen 93% 2455 No Reference No. NS Nitrous Oxide No Reference No. Nitrogen No Reference No. Nitrogen 97% NS No Reference No. NS Low Oxygen Nitrogen 1685 NS NS Carbon Dioxide No Reference No. Medicinal Air 1238 No Reference No. NS Synthetic Medicinal Air 1684 NS NS Helium NS Nitric Oxide 1550 NS NS Argon 2407 IP NS Methane IP IP NS Carbon Monoxide 2408 IP NS NS: IP: Not specified In preparation Each monograph defines the specification of the medicinal gas, including the: assay of the product; maximum allowable impurity levels for those contaminants specified in the product; approved analytical method for identifying the gas; approved analytical method for determining the assay, and approved analytical test method for determining each contaminant specified within the monograph. The validated analytical methods described in the monographs are the official test methods upon which the specifications in the relevant Pharmacopoeia are based. 2

6 3.1 European Pharmacopoeia test requirements For the European Pharmacopoeia, the test methods are verified against the protocols set out in the ICH Guidelines for accuracy and precision, linearity and range and specificity. The results also need to conform to the requirements of repeatability and peak symmetry. In addition to the specific medicinal gas monographs there are several general notices that apply to all monographs. The following general test methods are particularly applicable to the analysis of medical gases: Test Reference Test Method Gas s Gas Chromatography Chromatographic Separation Techniques Carbon Dioxide in Gases Carbon Monoxide in Gases Nitrogen Monoxide and Nitrogen Dioxide in Gases Oxygen in Gases Water in Gases Alternative methods of analysis may be used for testing medical gases, after agreement with the competent authority, provided that the test methods have been validated in line with the ICH protocols to demonstrate that they are equivalent to the specified methods. The European Pharmacopoeia monographs test methods specified for medical gases are divided into two main sections: The PRODUCTION methods are intended to be the methods used by the manufacturers. These methods are the basis for the release of the product at the manufacturer s site for patient use. The methods specified in the PRODUCTION section of the monograph normally utilise the latest analytical instruments, that should be available to the manufacturers of the gases. The TEST methods are intended to be the methods used by the end user to assure themselves that the medical gases are of the appropriate quality. For example, these could be used for routine testing by the Pharmacist at the hospital of the pipeline gases at the terminal outlets in the hospital. The TEST methods generally utilise detector tubes for the test method as it is unlikely that the end users would have all of the appropriate analytical instruments available to them for testing. Where the hospital is the manufacturer, for example where they are producing medicinal air on site using an air compressor, the PRODUCTION test methods should be applied. The United States and Japanese Pharmacopoeia monographs only specify one method for the analysis of the medical gas. These test methods utilise either detector tubes or wet chemistry techniques as the approved test method. The Japanese Pharmacopoeia monographs only detail the test methods and do not give the values of the specification limits in percentage terms or parts per million. In all cases the test methods specified in the monographs should have been validated. For the European Pharmacopoeia, this work is normally undertaken by one of the national representative on the relevant Pharmacopoeia committee. 3

7 4 Currency of Information The version of the relevant Pharmacopoeias used to provide the information for the comparison tables is: European Pharmacopoeia: 7.0 (July 2010) United States Pharmacopoeia: USP33, NF28 (2010) Japanese Pharmacopoeia: 15 (April 2006) As and when there are relevant changes to any of these monographs this comparison document will be updated. However, where it is important that the latest information is available, the original Pharmacopoeia document should be referenced to ensure that there have been no revisions to the individual monograph. 5 Comparison tables The following tables provide a comparison between the European and US Pharmacopoeia monographs for each of the specified medicinal or pharmaceutical gas. 4

8 5.1 Medical Oxygen Oxygen Monograph Ph Eur USP Name Oxygen Oxygen Reference Chemical Formula O 2 O 2 Oxygen contains not less than 99.5% V/V of O2. It is produced by a purification process followed by the distillation of the liquefied ambient air Complies with the Oxygen contains not less than 99.0% V/V of O 2. (Note: Oxygen produced by the airliquefaction is exempt from the requirements of and 2 testing) Complies with the Distinction from 2 detector tube Specification 99.5% V/V O % V/V O 2 Paramagnetic Analyser Volumetric Gas Absorption Apparatus 5 ppm V/V 0.001% V/V 2 Odour 2 Infrared analyser Detector tube 300 ppm V/V 0.03% V/V Infrared analyser Detector tube 67 ppm V/V Electrolytic hygrometer 5 ppm V/V 300 ppm V/V 67 ppm V/V No odour Organoleptic No Section specified 5

9 5.2 93% Oxygen Oxygen 93 Monograph Ph Eur USP Name Oxygen (93 per cent) Oxygen 93 Percent Reference 2455 Chemical Formula O 2 O 2 Oxygen 93% contains between 90.0%V/V and 96% V/V of O 2. Oxygen 93 is Oxygen produced from Air by molecular sieve process. Remainder mainly consists of argon Contains not less than 90.0 % V/V and nitrogen. Monograph applies to oxygen used on the site where produced. It does not apply to individual concentrators. and not more than 96 % O 2 V/V, the Remainder consists of mostly Argon and Nitrogen 2 Odour NO/ NO2 SO2 Oil 2 NO/ NO2 SO2 Oil Complies with the. 6 Complies with the. Distinction from 2 (detector tube) Specification 90.0% O % V/V O2 90.0% O % V/V O2 Paramagnetic analyser Volumetric Gas Absorption 5 ppm V/V % V/V Infrared analyser Detector tube 300 ppm V/V 0.03 % V/V Infrared analyser Detector tube 67 ppm V/V Electrolytic hygrometer 2 ppm V/V in total Chemiluminescence Analyser 1 ppm V/V UV Fluorescence Analyser 0.1 mg/m 3 5 ppm V/V 300 ppm V/V 67 ppm V/V 2 ppm V/V 1 ppm V/V 0.1 mg/m3 No odour Organoleptic No specific Section

10 5.3 Nitrous Oxide Nitrous Oxide Monograph Ph Eur USP Name Nitrous Oxide Nitrous Oxide Reference Chemical Formula N 2 O N 2 O Contains not less than 98.0% V/V of N 2 O in the gaseous phase, when sampled at 15 C. Complies with the assay. or - Place a glowing splinter of wood in the substance to be examined. The splinter bursts into flame. or - Introduce the substance to be examined into alkaline pyrogallol solution R. A brown colour does not develop. Nitrous Oxide contains not less than 99.0% V/V of N 2 O Comparison of pressure between N 2 O container and certified standard. Distinction from 2 detector tube. Distinction from O 2 (alkaline pyrogallol solution) 98.0% V/V N 2 O 1.0% air indicating Measured in gas phase at 15 O C 99.0% V/V of N2O Infrared analyser Gas Chromatography 2 NO/ NO2 NH3 Halogens 2 NO/ NO2 5 ppm V/V 0.001% V/V Gas Chromatography Detector tube 300 ppm V/V 0.03% V/V Gas Chromatography Detector tube 2 ppm V/V in total in the gaseous and liquid phases NO 1ppm, NO 2 1ppm Chemiluminescence Analyser 67 ppm V/V 150 mg/m 3 Electrolytic hygrometer 5 ppm V/V 300 ppm V/V 2 ppm V/V 67 ppm V/V % V/V 1ppm No specific Section 7

11 5.4 Nitrogen Nitrogen Monograph Ph Eur USP Name Nitrogen Nitrogen Reference Chemical Formula N2 N2 Nitrogen contains not less than Nitrogen contains not less than 99.5% V/V of N2. Retention time of peak with Gas Chromatography or Place a glowing splinter of wood in the substance to be examined. The splinter is extinguished. or Test with magnesium turnings 99.5% V/V N %,by volume of N2 Extinguishing of burning wood splinter in a Nitrogen test tube. 1.0% O 2 indicates 99.0% V/V of Gas Chromatography Gas Chromatography 5 ppm V/V % V/V Infrared analyser Detector tube 2 O2 Odour ppm V/V Infrared analyser N 2 Not specified 50 ppm V/V 1.0 % Oxygen Analyser with electrochemical cell Determined in 67 ppm V/V Electrolytic hygrometer Not specified Not specified 5 ppm V/V 300 ppm V/V 67 ppm V/V No odour Organoleptic No specific Section 8

12 5.5 97% Nitrogen Nitrogen 97% Monograph Name Reference Ph Eur No equivalent European Pharmacopoeia monograph USP Nitrogen 97 Percent Chemical Formula N 2 2 SO2 NO/ NO2 O2 Odour Nitrogen 97 Percent is Nitrogen produced from Air by physical separation. Contains not less than 97.0% N 2 V/V Extinguishing of burning wood splinter in a Nitrogen test tube. 3.0% O 2 indicates 97.0% V/V of N 2 Gas Chromatography % V/V Detector tube 0.03 % V/V Detector tube 5 ppm V/V Detector tube 2.5 ppm V/V 3.0 % V/V Gas Chromatography (determined in the ) No odour Organoleptic No specific Section 9

13 5.6 Low Oxygen Nitrogen Low Oxygen Nitrogen Monograph Ph Eur USP No equivalent US Pharmacopoeia Name Nitrogen Low Oxygen monograph Reference 1685 Chemical Formula N 2 O2 This monograph applies to Nitrogen which is used for inerting finished medicinal products sensitive to degradation by oxygen. Does not necessarily apply to N2 used in earlier production steps of pharmaceutical manufacturing. Examine the chromatograms obtained in the test for impurities. or - Flame of burning wood splinter in a Nitrogen test tube/ Test with magnesium turnings. 99.5% V/V N2 Gas Chromatography 5 ppm V/V O2 Oxygen Analyser with electrochemical cell No Test Section specified 10

14 5.7 Carbon Dioxide Carbon Dioxide Monograph Ph Eur USP Name Carbon Dioxide Carbon Dioxide Reference Chemical Formula 2 2 Carbon Dioxide contains not less than 99.5% V/V of 2.in gaseous phase. Infrared absorption spectrophotometry or - Glowing wood splinter extinguished or - test with magnesium turnings Carbon Dioxide contains not less than 99.0%,by volume of 2 Carbon Dioxide 99.5% V/V % V/V of 2 Infrared analyser Determined with volumetric gas absorption apparatus 5 ppm V/V 0.001% V/V Gas Chromatography Detector tube NO/ NO2 Total Sulfur NH3 H2S SO2 SO2 H2S NO/ NO2 2 ppm V/V in total (in gas phase) 2.5 ppm (in liquid phase) specifies 2.5 ppm for each species. Chemiluminescence Analyser Detector tube 1 ppm V/V UV Fluorescence Analyser 67 ppm V/V 150 mg/m3 Electrolytic hygrometer Detector tube 5 ppm V/V 2 ppm V/V 1 ppm V/V 2 ppm V/V 67 ppm V/V % V/V Detector tube 1 ppm Detector tube 5 ppm Detector tube No specific Section 11

15 5.8 Medicinal Air Medicinal Air Monograph Ph Eur USP Name Air, Medicinal Medical Air Reference 1238 Chemical Formula N/A N/A Compressed ambient air containing not less than 20.4 %V/V and not more than 21.4 % V/V of O 2. 2 SO2 NO/ NO2 Oil Odo ur Complies with the or Glowing wood splinter not extinguished or Oxygen content tested by passing sample through potassium hydroxide/sodium dithionite solution. 12 Natural or synthetic mixture consisting largely of N 2 and O 2, containing not less than 19.5% and not more than 23.5% V/V of O %V/V O % V/V 19.5% V/V O % V/V Paramagnetic Analyser Oxygen Analyser with electrochemical cell 5 ppm V/V 0.001% V/V Infrared Analyser Detector tube 500 ppm V/V 0.05% V/V Infrared Analyser Detector tube 1 ppm V/V 5 ppm V/V UV Fluorescence Analyser Detector tube 2 ppm V/V in total 2.5 ppm V/V Chemiluminescence Analyser 0.1 mg/m 3 No condensate on mirror Detector tube when an oil lubricated Pass gas slowly over stainless steel compressor is used for production mirror 67 ppm V/V No condensate on mirror Electrolytic hygrometer Pass gas slowly over stainless steel mirror No odour Not specified Organoleptic 5 ppm V/V 500 ppm V/V 1 ppm V/V 2 ppm V/V 0.1 mg/m 3 67 ppm V/V NO/ 2 SO2 Oil NO2 No Specific Section

16 5.9 Synthetic Medicinal Air Synthetic Medicinal Air Monograph Ph Eur USP Name Air, Synthetic Medicinal No equivalent US Pharmacopoeia Reference 1684 monograph specified Chemical Formula N/A Gas mixture of N2 (Ph.Eur) and O2 (Ph.Eur) containing between 95.0 % to % of the nominal value which is between 21.0 % V/V to 22.5 % V/V of O2. Complies with the or Glowing wood splinter not extinguished or Oxygen content tested by passing sample through potassium hydroxide/sodium dithionite solution. Containing between 95.0% to 105.0% of the nominal value which is between 21.0 % V/V to 22.5 % V/V of O2. Paramagnetic analyser 67 ppm V/V O2 Electrolytic hygrometer 67 ppm V/V O2 13

17 5.10 Helium Helium Monograph Ph Eur USP Name Helium Helium Reference Chemical Formula He He Helium contains not less than 99.5 % V/V of He. Applies to helium obtained by separation from natural gas supplies. Helium contains not less than 99.0 % V/V of He Complies with the The flame of a burning splinter of wood is extinguished. A small balloon filled with helium shows decided buoyancy Specification 99.5 % V/V He 99.0 % V/V He Gas Chromatography Gas chromatography 50 ppm V/V CH4 O2 Air Odour Infrared analyser 50 ppm V/V Electrochemical Cell 67 ppm V/V Electrolytic hygrometer No Section specified % V/V 1.0 % V/V Determined in the No odour Organoleptic No Section specified 14

18 5.11 Nitric Oxide Nitric Oxide Monograph Ph Eur USP Name Nitric Oxide No equivalent US Pharmacopoeia Reference 1550 monograph specified Chemical Formula NO Nitric oxide contains not less than 99.0% V/V of NO. Examine by infrared spectrometry and compare with the reference spectrum Specification 99.0 % V/V NO 2 N2 NO2 N2O Determine content of NO by difference using the mass balance equation after determining the sum of the impurities described under production ppm V/V Gas Chromatography 3000 ppm V/V Gas Chromatography 400 ppm V/V UV Spectrophotometry Analyser 3000 ppm V/V Gas Chromatography 100 ppm V/V Electrolytic Hygrometer No Section specified 15

19 5.12 Argon Argon Monograph Ph Eur USP Name Argon No equivalent US Pharmacopoeia Reference 07/2010:2407 monograph specified Chemical Formula Ar Gas obtained by fractional distillation. Argon contains not less than % v/v of Ar calculated by deduction of the sum of impurities found when performing the test for impurities and water content.. Gas chromatography and verify that the gas is not oxygen using a paramagnetic analyser. Specification % V/V Ar Gas Chromatography 5 ppm V/V Gas Chromatography O2 10 ppm V/V Electrolytic Hygrometer No Section specified 16

20 5.13 Carbon Monoxide Carbon Monoxide Monograph Ph Eur USP Name Carbon Monoxide No equivalent US Pharmacopoeia Reference 01/2011:2408 monograph specified Chemical Formula Gas obtained by steam reforming (catalytic oxidation) of hydrocarbons. Carbon monoxide contains not less than 99.5% V/V of. Infrared absorption spectrophotometry or it complies with the limits of the assay. Specification 99.5 % V/V Infrared analyser 300 ppm V/V Gas Chromatography 2 CH4 H2 Nickel tetracarbonyl / Iron pentacarbonyl 100 ppm V/V Gas Chromatography 300 ppm V/V Gas Chromatography Not detectable Detector tube 10 ppm V/V Electrolytic Hygrometer No Section specified 17

21 6 Japanese Pharmacopoeia 6.1 Medical Oxygen Oxygen Monograph Name JP Medical Oxygen Chemical Formula O 2 Oxygen contains not less than 99.5%vol of O2. Description Purity Oxygen is a colourless, odourless gas. 1. Put a glowing splinter of wood into the oxygen: it bursts into flames immediately 2. The retention time of the principle peak for oxygen coincides with that of oxygen for chromatography Acidity or alkalinity Oxidising Substances Chloride 2 N2 Colour of the test solution is not deeper than the reference solutions Pass through methyl red and bromothymol blue acidified solution in a Nessler tube. Compare colour against control solution The colour is the same as the control solution Pass through potassium iodide-starch solution in a Nessler tube. Compare colour against control solution Turbidity produced does not exceed that produced in the control solution (can be calculated by the method) Pass through silver nitrate solution in a Nessler tube. Compare turbidity against control solution Turbidity produced does not exceed that produced in the control solution (can be calculated by the method) Pass through barium hydroxide in a Nessler tube. Compare turbidity against a control solution of barium hydroxide containing hydrogen carbonate The peak area of nitrogen in the oxygen is not larger than that of the control sample Gas Chromatography Specification 99.5% vol of O 2. Volumetric Gas Absorption Apparatus 18

22 6.2 Nitrous Oxide Nitrous Oxide Monograph Name Chemical Formula Description Purity JP Nitrous Oxide N 2 O Nitrous oxide contains not less than 97 vol% of N 2 O Nitrous oxide is a colourless, odourless gas at room temperature and at atmospheric pressure. 1 Put a glowing splinter of wood into nitrous oxide: it bursts into flame immediately. 2. The retention time of the main peak from nitrous oxide coincides with that of nitrous oxide by gas chromatography. Acidity or alkalinity Reducing Substances Oxidising Substances Chloride 2 Colour of the test solution is not deeper than the reference solutions Pass through acidified methyl red and bromothymol blue test solution in a Nessler tube. Compare colour against control solution The colour is the same as the control solution Pass through potassium permanganate solution in a Nessler tube. Compare colour against control solution The colour is the same as the control solution Pass through potassium iodide-starch solution in a Nessler tube. Compare colour against control solution Turbidity produced does not exceed that produced in the control solution (can be calculated by the method) Pass through silver nitrate solution in a Nessler tube. Compare turbidity against control solution Turbidity produced does not exceed that produced in the control solution (can be calculated by the method) Pass through barium hydroxide in a Nessler tube. Compare turbidity against control solution of barium hydroxide containing sodium hydrogen carbonate No peak observed at the same retention time as that for carbon monoxide Gas Chromatography Specification 97.0 vol% of N 2 O. Gas chromatography 19

23 6.3 Carbon Dioxide Carbon Dioxide Monograph Name JP Carbon Dioxide Chemical Formula 2 Carbon Dioxide contains not less than 99.5 vol% of 2 Description Purity Carbon Dioxide is a colourless, odourless gas at room temperature and under atmospheric pressure. 1 Put a flaming splinter of wood into carbon dioxide and the flame is extinguished immediately. 2. Pass carbon dioxide into calcium hydroxide and a white precipitate is produced. Add acetic acid to the precipitate and it dissolves with effervescence. Acidity Reducing Substances* Oxygen & Nitrogen The test solution is not more coloured than the control solution. Pass through water in a Nessler tube and add methyl orange detector. Compare colour against control solution. The turbidity is the same as the control solution. Pass through silver nitrate solution in a Nessler tube. Compare turbidity against control solution. No peak is observed at the same retention time as that for carbon monoxide. Gas Chromatography. The peak area of air in carbon dioxide by chromatography is less than that of 0.5 % vol N 2. No other peak appears. Gas Chromatography. Specification 99.5 vol% of 2. Volumetric Gas Absorption Apparatus * Reducing substances includes test for phosphine (PH 3 ) hydrogen sulphide (H 2 S) and reducing organic substances. 20

24 6.4 Nitrogen Nitrogen Monograph Name JP Nitrogen Chemical Formula N 2 Nitrogen contains not less than 99.5 vol% of N 2 Description Purity Nitrogen is a colourless, odourless gas. Put a burning wood splinter into nitrogen and the flame is extinguished immediately. 2 Not specified (can be calculated by the method) Pass through barium hydroxide in a Nessler tube. Compare turbidity against control solution of barium hydroxide containing hydrogen carbonate Specification 99.5 vol% of N 2. Gas chromatography. 21