EUROPEAN PHARMACOPOEIA 10.

0 Nitrous oxide

C. In a suitable test tube, place 0.1 g of magnesium R in Impurities. Gas chromatography (2.2.28).
turnings. Close the tube with a two-hole stopper fitted with
Gas to be examined. The substance to be examined.
a glass tube reaching about 1 cm above the turnings. Pass
Reference gas (a). Use ambient air.
the substance to be examined through the glass tube for
Reference gas (b). Use nitrogen R1.
1 min without heating, then for 15 min while heating the
Column :
test tube to a red glow. After cooling, add 5 mL of dilute
sodium hydroxide solution R. The evolving vapours change
– material : stainless steel,
the colour of moistened red litmus paper R blue. – size : l = 2 m, Ø = 2 mm,
TESTS – stationary phase : appropriate molecular sieve for
chromatography (0.5 nm).
Carbon dioxide (2.1.6) : maximum 300 ppm V/V, determined
using a carbon dioxide detector tube. Carrier gas : helium for chromatography R.
Carbon monoxide (2.1.6) : maximum 5 ppm V/V, determined Flow rate : 40 mL/min.
using a carbon monoxide detector tube. Temperature :
Water vapour (2.1.6) : maximum 67 ppm V/V, determined – column : 50 °C,
using a water vapour detector tube. – detector : 130 °C.
Detection : thermal conductivity.
STORAGE
System suitability : reference gas (a) : adjust the injected
As a compressed gas or a liquid in appropriate containers volumes and operating conditions so that the height of the
complying with the legal regulations.
peak due to nitrogen in the chromatogram obtained is at least
IMPURITIES 35 per cent of the full scale of the recorder :
Specified impurities : A, B, C, D. – the chromatogram obtained shows a clear separation of
oxygen and nitrogen.
A. CO2 : carbon dioxide,
Limit :
B. CO : carbon monoxide, – total : not more than 0.5 per cent of the sum of the areas of
C. O : oxygen, all the peaks (0.5 per cent V/V).
2

D. H2O : water. IDENTIFICATION

01/2008:1685 Second identification : B, C.
NITROGEN, LOW-OXYGEN
Nitrogenium oxygenio depletum
N2 Mr 28.01
DEFINITION
This monograph applies to nitrogen which is used for inerting
finished medicinal products which are particularly sensitive
to degradation by oxygen. It does not necessarily apply to
nitrogen used in earlier production steps.
Content : minimum 99.5 per cent V/V of N2, calculated by
deduction of the sum of impurities found when performing
the test for impurities.
CHARACTERS
Colourless and odourless gas.
Solubility : at 20 °C and at a pressure of 101 kPa, 1 volume
dissolves in about 62 volumes of water and about 10 volumes IMPURITIES
of alcohol.
PRODUCTION
Oxygen : maximum 5 ppm V/V, determined using an oxygen
analyser with a detector scale ranging from 0 ppm V/V to
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 manufacturer’s
instructions. 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.
First identification : A.
A. Examine the chromatograms obtained in the test for
impurities (see Production).
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
reference gas (b).
B. In a 250 mL conical flask replace the air by the gas to be
examined. Place a burning or glowing splinter of wood in
the flask. The splinter is extinguished.
C. In a suitable test tube, place 0.1 g of magnesium R in
turnings. Close the tube with a two-hole stopper fitted with
a glass tube reaching about 1 cm above the turnings. Pass
the gas to be examined through the glass tube for 1 min
without heating, then for 15 min while heating the test tube
to a red glow. After cooling, add 5 mL of dilute sodium
hydroxide solution R. The evolving vapours turn the colour
of moistened red litmus paper R blue.
STORAGE
Where the gas has to be stored, store as a compressed gas or
a liquid in appropriate containers complying with the legal
regulations.
A. O2 : oxygen,
B. Ar : argon.
01/2008:0416
NITROUS OXIDE
Dinitrogenii oxidum
N2O Mr 44.01
[10024-97-2]

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