Nitrogen

EUROPEAN PHARMACOPOEIA 7.0

Water (2.5.28) : maximum 67 ppm V/V.

Assay. Gas chromatography (2.2.28).
Gas to be examined. The substance to be examined.
Reference gas (a). Ambient air.
Reference gas (b). Nitrogen R1.
Column :
material : stainless steel ;
size : l = 2 m, = 2 mm ;
stationary phase : molecular sieve for chromatography R
(0.5 nm).
Carrier gas : helium for chromatography R.
STORAGE
Flow rate : 40 mL/min.
Store protected from light, at a temperature below 25 C.
Temperature :
01/2008:1247 column : 50 C ;
detection : 130 C.
Detection : thermal conductivity.
NITROGEN
Injection : loop injector.
Nitrogenium
Inject reference gas (a). Adjust the injected volumes and
operating conditions so that the height of the peak due to
N2
Mr 28.01 nitrogen in the chromatogram obtained with the reference gas
is at least 35 per cent of the full scale of the recorder.
[7727-37-9]
System suitability :
DEFINITION
the chromatograms obtained show a clear separation of
Content : minimum 99.5 per cent V/V of N2.
oxygen and nitrogen.
This monograph applies to nitrogen for medicinal use.
Calculate the content of N2 in the gas to be examined.
CHARACTERS
IDENTIFICATION
Appearance : colourless, odourless gas.
First identification : A.
Solubility : at 20 C and at a pressure of 101 kPa, 1 volume
Second identification : B, C.
dissolves in about 62 volumes of water and about 10 volumes
A. Examine the chromatograms obtained in the assay (see
of ethanol (96 per cent).
Production).
PRODUCTION
Results : the principal peak in the chromatogram obtained
with the substance to be examined is similar in retention
Carbon dioxide : maximum 300 ppm V/V, determined using
time to the principal peak in the chromatogram obtained
an infrared analyser (2.5.24).
with reference gas (b).
Gas to be examined. The substance to be examined. It must be
B. In a 250 mL conical flask replace the air by the substance to
filtered to avoid stray light phenomena.
be examined. Place a burning or glowing splinter of wood in
Reference gas (a). Nitrogen R1.
the flask. The splinter is extinguished.
Reference gas (b). Mixture containing 300 ppm V/V of carbon
C.
In a suitable test tube, place 0.1 g of magnesium R in
dioxide R1 in nitrogen R1.
turnings. Close the tube with a two-hole stopper fitted with
Calibrate the apparatus and set the sensitivity using reference
a glass tube reaching about 1 cm above the turnings. Pass
gases (a) and (b). Measure the content of carbon dioxide in the
the substance to be examined through the glass tube for
gas to be examined.
1 min without heating, then for 15 min while heating the
Carbon monoxide : maximum 5 ppm V/V, determined using
test tube to a red glow. After cooling, add 5 mL of dilute
an infrared analyser (2.5.25).
sodium hydroxide solution R. The evolving vapours change
the colour of moistened red litmus paper R blue.
Gas to be examined. The substance to be examined. It must be
filtered to avoid stray light phenomena.
TESTS
Reference gas (a). Nitrogen R1.
Carbon dioxide (2.1.6) : maximum 300 ppm V/V, determined
Reference gas (b). Mixture containing 5 ppm V/V of carbon
using a carbon dioxide detector tube.
monoxide R in nitrogen R1.
Carbon monoxide (2.1.6) : maximum 5 ppm V/V, determined
Calibrate the apparatus and set the sensitivity using reference
using a carbon monoxide detector tube.
gases (a) and (b). Measure the content of carbon monoxide in
Water vapour (2.1.6) : maximum 67 ppm V/V, determined using
the gas to be examined.
a water vapour detector tube.
Oxygen : maximum 50 ppm V/V, determined using an oxygen

ASSAY
Carry out the assay protected from bright light. Dissolve
0.120 g in 50 mL of dimethylformamide R and dilute to
1000.0 mL with water R. Dilute 5.0 mL of the solution to
100.0 mL with a solution containing 18 g/L of sodium
acetate R and 0.14 per cent V/V of glacial acetic acid R.
Measure the absorbance (2.2.25) at the absorption maximum
at 367 nm, using the sodium acetate solution described above
as compensation liquid.
Calculate the content of C8H6N4O5, taking the specific
absorbance to be 765.

analyser with a detector scale ranging from 0-100 ppm V/V and
equipped with an electrochemical cell.
The gas to be examined passes through a detection cell
containing an aqueous solution of an electrolyte, generally
potassium hydroxide. The presence of oxygen in the gas to be
examined produces variation in the electric signal recorded at
the outlet of the cell that is proportional to the oxygen content.
Calibrate the analyser according to the instructions of the
manufacturer. Pass the gas to be examined through the
analyser using a suitable pressure regulator and airtight metal
tubes and operating at the prescribed flow-rates until constant
readings are obtained.

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STORAGE
As a compressed gas or a liquid in appropriate containers
complying with the legal regulations.
IMPURITIES
Specified impurities : A, B, C, D.
A. CO2 : carbon dioxide,
B. CO : carbon monoxide,
C. O2 : oxygen,
D. H2O : water.

See the information section on general monographs (cover pages)

Nitrous oxide

EUROPEAN PHARMACOPOEIA 7.0

01/2008:1685

Results : the principal peak in the chromatogram obtained

with the gas to be examined is similar in retention time
to the principal peak in the chromatogram obtained with
NITROGEN, LOW-OXYGEN
reference gas (b).
B.
In a 250 mL conical flask replace the air by the gas to be
Nitrogenium oxygenio depletum
examined. Place a burning or glowing splinter of wood in
the flask. The splinter is extinguished.
N2
Mr 28.01
C. In a suitable test tube, place 0.1 g of magnesium R in
DEFINITION
turnings. Close the tube with a two-hole stopper fitted with
a glass tube reaching about 1 cm above the turnings. Pass
This monograph applies to nitrogen which is used for inerting
the gas to be examined through the glass tube for 1 min
finished medicinal products which are particularly sensitive to
without heating, then for 15 min while heating the test tube
degradation by oxygen. It does not necessarily apply to nitrogen
to a red glow. After cooling, add 5 mL of dilute sodium
used in earlier production steps.
hydroxide solution R. The evolving vapours turn the colour
Content : minimum 99.5 per cent V/V of N2, calculated by
of moistened red litmus paper R blue.
deduction of the sum of impurities found when performing the
test for impurities.
STORAGE
Where the gas has to be stored, store as a compressed gas or
CHARACTERS
a liquid in appropriate containers complying with the legal
Colourless and odourless gas.
regulations.
Solubility : at 20 C and at a pressure of 101 kPa, 1 volume
IMPURITIES
dissolves in about 62 volumes of water and about 10 volumes
of alcohol.
A. O2 : oxygen,
PRODUCTION
B. Ar : argon.
Oxygen : maximum 5 ppm V/V, determined using an oxygen
01/2008:0416
analyser with a detector scale ranging from 0 ppm V/V to
100 ppm V/V and equipped with an electrochemical cell.
NITROUS OXIDE
The gas to be examined passes through a detection cell
containing an aqueous solution of an electrolyte, generally
potassium hydroxide. The presence of oxygen in the gas to be
Dinitrogenii oxidum
examined produces variation in the electric signal recorded at
the outlet of the cell that is proportional to the oxygen content. N2O
Mr 44.01
[10024-97-2]
Calibrate the analyser according to the manufacturers
instructions. Pass the gas to be examined through the analyser
DEFINITION
using a suitable pressure regulator and airtight metal tubes and
Content : minimum 98.0 per cent V/V of N2O in the gaseous
operating at the prescribed flow rates until constant readings
phase, when sampled at 15 C.
are obtained.
This monograph applies to nitrous oxide for medicinal use.
Impurities. Gas chromatography (2.2.28).
Gas to be examined. The substance to be examined.
CHARACTERS
Reference gas (a). Use ambient air.
Appearance: colourless gas.
Reference gas (b). Use nitrogen R1.
Solubility : at 20 C and at a pressure of 101 kPa, 1 volume
dissolves in about 1.5 volumes of water.
Column :
material : stainless steel,
PRODUCTION
size : l = 2 m, = 2 mm,
Nitrous oxide is produced from ammonium nitrate by thermic
stationary phase : appropriate molecular sieve for
decomposition.
chromatography (0.5 nm).
Examine the gaseous phase.
Carrier gas : helium for chromatography R.
If the test is performed on a cylinder, keep the cylinder at
Flow rate: 40 mL/min.
room temperature for at least 6 h before carrying out the tests.
Keep the cylinder in the vertical position with the outlet valve
Temperature :
uppermost.
column : 50 C,
Carbon dioxide. Gas chromatography (2.2.28).
detector : 130 C.
Gas to be examined. The substance to be examined.
Detection : thermal conductivity.
Reference gas. A mixture containing 300 ppm V/V of carbon
System suitability : reference gas (a) : adjust the injected
volumes and operating conditions so that the height of the peak dioxide R1 in nitrous oxide R.
due to nitrogen in the chromatogram obtained is at least 35 per Column :
cent of the full scale of the recorder :
material : stainless steel ;
the chromatogram obtained shows a clear separation of
size : l = 3.5 m, = 2 mm ;
oxygen and nitrogen.
stationary phase : ethylvinylbenzene-divinylbenzene
Limit :
copolymer R.
total : not more than 0.5 per cent of the sum of the areas of
Carrier gas : helium for chromatography R.
all the peaks (0.5 per cent V/V).
Flow rate : 15 mL/min.
Temperature :
IDENTIFICATION
column : 40 C ;
First identification : A.
detector : 90 C.
Second identification : B, C.
Detection
: thermal conductivity.
A. Examine the chromatograms obtained in the test for
impurities (see Production).
Injection : loop injector.
General Notices (1) apply to all monographs and other texts

2585