EUROPEAN PHARMACOPOEIA 10.

8 Air, medicinal

07/2022:1238 Reference gas (b). Use a mixture of 21 per cent V/V of oxygen R

and 79 per cent V/V of nitrogen R1, containing 5 ppm V/V
of carbon monoxide R.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of carbon monoxide in
AIR, MEDICINAL the gas to be examined.
Sulfur dioxide : maximum 1 ppm V/V, determined using an
ultraviolet fluorescence analyser (Figure 1238.-1).
Aer medicinalis
The apparatus consists of the following :
DEFINITION – a system generating ultraviolet radiation with a wavelength
Compressed ambient air. of 210 nm, made up of an ultraviolet lamp, a collimator,
and a selective filter ; the beam is blocked periodically by a
Content : 20.4 per cent V/V to 21.4 per cent V/V of oxygen (O2). chopper rotating at high speeds ;
CHARACTERS – a reaction chamber, through which flows the gas to be
examined ;
Appearance : colourless gas.
– a system that detects radiation emitted at a wavelength of
Solubility : at 20 °C at a pressure of 101 kPa, 1 volume dissolves 350 nm, made up of a selective filter, a photomultiplier
in about 50 volumes of water. tube and an amplifier.
PRODUCTION Gas to be examined. Filter the substance to be examined.
Carbon dioxide : maximum 500 ppm V/V, determined using Reference gas (a). Use a mixture of 21 per cent V/V of oxygen R
an infrared analyser (2.5.24). and 79 per cent V/V of nitrogen R1.
Reference gas (b). Use a mixture of 21 per cent V/V of oxygen R
Gas to be examined. Filter the substance to be examined to
and 79 per cent V/V of nitrogen R1, containing 0.5 ppm V/V
avoid stray light phenomena.
to 2 ppm V/V of sulfur dioxide R1.
Reference gas (a). Use a mixture of 21 per cent V/V of oxygen R Calibrate the apparatus and set the sensitivity using reference
and 79 per cent V/V of nitrogen R1, containing less than gases (a) and (b). Measure the content of sulfur dioxide in
1 ppm V/V of carbon dioxide R1. the gas to be examined.
Reference gas (b). Use a mixture of 21 per cent V/V of oxygen R Oil : maximum 0.1 mg/m3, determined using an oil detector
and 79 per cent V/V of nitrogen R1, containing 500 ppm V/V tube (2.1.6), when an oil-lubricated compressor is used for
of carbon dioxide R1. the production.
Calibrate the apparatus and set the sensitivity using reference Nitrogen monoxide and nitrogen dioxide : maximum
gases (a) and (b). Measure the content of carbon dioxide in 2 ppm V/V in total, determined using a chemiluminescence
the gas to be examined. analyser (2.5.26).
Carbon monoxide : maximum 5 ppm V/V, determined using Gas to be examined. The substance to be examined.
an infrared analyser (2.5.25). Reference gas (a). Use a mixture of 21 per cent V/V of oxygen R
Gas to be examined. Filter the substance to be examined to and 79 per cent V/V of nitrogen R1, containing less than
avoid stray light phenomena. 0.05 ppm V/V of nitrogen monoxide and nitrogen dioxide.
Reference gas (a). Use a mixture of 21 per cent V/V of oxygen R Reference gas (b). Use a mixture of 21 per cent V/V of oxygen R
and 79 per cent V/V of nitrogen R1, containing less than and 79 per cent V/V of nitrogen R1, containing 2 ppm V/V
1 ppm V/V of carbon monoxide R. of nitrogen dioxide R.

Figure 1238.-1. – UV fluorescence analyser

General Notices (1) apply to all monographs and other texts 6881
Air, medicinal
Calibrate the apparatus and set the sensitivity using reference
B. Use a gas burette (Figure 1238.-2) of 25 mL capacity in
gases (a) and (b). Measure the content of nitrogen monoxide
and nitrogen dioxide in the gas to be examined.
Water: maximum 67 ppm V/V, determined using an
electrolytic hygrometer (2.5.28), except where the competent
authority decides that the following limit applies to medicinal olive-shaped nozzle and is used to introduce the gas into
air generated on-site and distributed in pipe-line systems
operating at a pressure not greater than 10 bar and a
temperature not less than 5 °C : maximum 870 ppm V/V,
determined using an electrolytic hygrometer (2.5.28).
Assay. Determine the concentration of oxygen in air using a
paramagnetic analyser (2.5.27).
IDENTIFICATION
First identification : C.
Second identification : A, B.
A. In a conical flask containing the substance to be examined,
place a glowing wood splinter. The splinter remains
glowing.
C. It complies with the limits of the assay.
Figure 1238.-2. – Gas burette
6882
EUROPEAN PHARMACOPOEIA 10.8
the form of a chamber in the middle of which is a tube
graduated in 0.2 per cent between 19.0 per cent and
23.0 per cent, and isolated at each end by a tap with a
conical barrel. The lower tap is joined to a tube with an
the apparatus. A cylindrical funnel above the upper tap
is used to introduce the absorbent solution. Wash the
burette with water R and dry. Open the 2 taps. Connect the
nozzle to the source of the gas to be examined and set the
flow rate to 1 L/min. Flush the burette by passing the gas
to be examined through it for 1 min. Close the lower tap
of the burette and immediately afterwards the upper tap.
Rapidly disconnect the burette from the source of the gas
to be examined. Rapidly give a half turn to the upper tap
to eliminate any excess pressure in the burette. Keeping
the burette vertical, fill the funnel with a freshly prepared
mixture of 21 mL of a 560 g/L solution of potassium
hydroxide R and 130 mL of a 200 g/L solution of sodium
dithionite R. Open the upper tap slowly. The solution
absorbs the oxygen and enters the burette. Allow to stand
for 10 min without shaking. Read the level of the liquid
meniscus on the graduated part of the burette. This figure
represents the percentage V/V of oxygen. The value read is
20.4 to 21.4.
TESTS
Carbon dioxide : maximum 500 ppm V/V, determined using
a carbon dioxide detector tube (2.1.6).
Sulfur dioxide : maximum 1 ppm V/V, determined using a
sulfur dioxide detector tube (2.1.6).
Oil : maximum 0.1 mg/m3, determined using an oil detector
tube (2.1.6), when an oil-lubricated compressor is used for
the production.
Nitrogen monoxide and nitrogen dioxide : maximum
2 ppm V/V, determined using a nitrogen monoxide and
nitrogen dioxide detector tube (2.1.6).
Carbon monoxide : maximum 5 ppm V/V, determined using
a carbon monoxide detector tube (2.1.6).
Water vapour : maximum 67 ppm V/V, determined using
a water vapour detector tube (2.1.6), except where the
competent authority decides that the following limit applies
to medicinal air generated on-site and distributed in pipe-line
systems operating at a pressure not greater than 10 bar and
a temperature not less than 5 °C : maximum 870 ppm V/V,
determined using a water vapour detector tube (2.1.6).
STORAGE
As a gas, in suitable containers complying with the legal
regulations or as a gas supplied by a pipe network.
LABELLING
Where applicable, the label states the production method and
any use of an oil-lubricated compressor.
IMPURITIES
A. CO2 : carbon dioxide,
B. SO2 : sulfur dioxide,
C. NO : nitrogen monoxide,
D. NO2 : nitrogen dioxide,
E. oil,
F. CO : carbon monoxide,
G. H2O : water.
See the information section on general monographs (cover pages)