The International Pharmacopoeia - Tenth Edition, 2020 Oxygen (Oxygenium)

Oxygen (Oxygenium)
O2

Relative molecular mass. 32.00

Chemical name. Oxygen; CAS Reg. No. 7782-44-7.

Description. A colourless gas; odourless.

Solubility. One volume dissolves in about 32 volumes of water and in about 7 volumes of ethanol (~750 g/l) TS, both at a
pressure of 101.3 kPa and 20°C.

Category. Gas for inhalation.

Storage. Oxygen should be kept as compressed gas or liquid at cryogenic temperature, in appropriate containers complying with
the safety regulations of the national authority. Valves or taps should not be lubricated with oil or grease.

Labelling. An ISO standard1 requires that cylinders containing oxygen intended for medical use should bear the name of the
contents in legible and permanent characters and, preferably, also the molecular formula O2.
1
International Standard 32. Gas cylinders for medical use - marking for identification of content. International
Organization for Standardization, Switzerland, 1977.

Additional information. In the analysis of medicinal gases certain tests are not intended for hospital pharmacists. They are solely
applicable by laboratories equipped with the specialized apparatus.

Requirements

Oxygen contains not less than 99.5% v/v of O2.

• Oxygen labelled as having been produced by the air-liquefaction process may be exempted from the requirements of the tests
for carbon monoxide and carbon dioxide.

Identity tests

A. Place a glowing splinter of wood into the test gas; the splinter bursts into flame.

B. Shake with alkaline pyrogallol TS; the test gas is absorbed and the solution becomes dark brown (distinction
from Dinitrogen oxide).

Figure 7.Apparatus for the determination of carbon monoxide in medicinal gases

Reproduced with the permission of the European Pharmacopoeia Commission, European Directorate for the Quality of
Medicines, Council of Europe.

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• Note: For the following tests deliver the test gas at a rate of 4 litres per hour.

Carbon monoxide

• Either test A or test B may be applied.

A. The apparatus (Fig. 7) consists of the following parts connected in series:

- a U-tube (U1) containing desiccant silica gel R impregnated with chromium trioxide R;

- a wash bottle (F1) containing 100 mL of potassium hydroxide (~400 g/l) TS;

- a U-tube (U2) containing pellets of potassium hydroxide R;

- a U-tube (U3) containing phosphorus pentoxide R dispersed on previously granulated, fused

- a U-tube (U4) containing 30 g of recrystallized iodine pentoxide R in granules, previously dried at

- a reaction tube (F2) containing 2.0 mL of potassium iodide (160 g/l) TS and 0.15 mL of starch TS.

Flush the apparatus with 5.0 litres of argon R. If necessary, discharge the blue colour in tube F2 containing
potassium iodide (160 g/l) TS by adding a sufficient volume of freshly prepared sodium thiosulfate (0.002 mol/l)
VS. Continue flushing with argon R until not more than 0.045 mL of sodium thiosulfate (0.002 mol/l) VS is required
after the passage of 5.0 litres of argon R. Pass 7.5 litres of the test gas from the container through the apparatus.
Flush the last traces of liberated iodine into the reaction tube by passing 1.0 litre of argon R through the
apparatus. Titrate the liberated iodine with sodium thiosulfate (0.002 mol/l) VS. Repeat the procedure using 7.5
litres of argon R.

B. Determine the content using a carbon monoxide detector tube. Pass the required volume of the test gas
through the tube, the calibration of which is verified according to the manufacturer's instructions.

The gas supply is connected to a pressure regulator and needle valve. Connect the flexible tubing fitted with a Y-
piece to the valve and adjust the flow of the test gas to purge the tubing to an appropriate flow. Fit the carbon
monoxide detector tube to the metering pump following the manufacturer's instructions. Connect the open end of
the tube to the short leg of the tubing and operate the pump sufficiently to pass a suitable volume of the test gas
through the tube. Read the value corresponding to the length of the coloured layer or the intensity of the colour on
the graduated scale; not more than 5 μl/l.

Note: For the following tests - "Carbon dioxide", "Oxidizing substances", and "Acidity and alkalinity" - pass the test gas through
the appropriate reagent contained in a hermetically closed flat-bottomed glass cylinder (with dimensions such that 50 mL of liquid
reaches a height of 12-14 cm) that is fitted with (a) a delivery tube terminated by a capillary 1 mm in internal diameter and placed
within 2 mm of the bottom of the cylinder; and (b) an outlet tube.

Prepare the reference solutions in identical cylinders.

Carbon dioxide

• Either test A or test B may be applied.

A. Pass 1.0 litre of the test gas through 50 mL of a clear solution of barium hydroxide (0.15 mol/l) VS. Similarly
prepare a reference solution by adding 1.0 mL of a 1.1 mg/mL solution of sodium hydrogen carbonate R in
carbon-dioxidefree water R to 50 mL of barium hydroxide (0.15 mol/l) VS.

Any turbidity in the solution after the passage of the test gas is not more intense than that of the reference solution
(300 μl/l).

B. Determine the content using a carbon dioxide detector tube. Pass the required volume of the test gas through
the tube, the calibration of which is verified according to the manufacturer's instructions.

The gas supply is connected to a suitable pressure regulator and needle valve. Connect the flexible tubing fitted
with a Y-piece to the valve and adjust the flow of the test gas to purge the tubing to an appropriate flow. Fit the
carbon dioxide detector tube to the metering pump following the manufacturer's instructions. Connect the open
end of the tube to the short leg of the tubing and operate the pump sufficiently to pass a suitable volume of the test
gas through the tube. Read the value corresponding to the length of the coloured layer or the intensity of the
colour on the graduated scale; not more than 300 μl/l.

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The International Pharmacopoeia - Tenth Edition, 2020 Oxygen (Oxygenium)

Oxidizing substances. To two cylinders add 50 mL of freshly prepared potassium iodide/starch TS1 and about 0.2 mL of glacial
acetic acid R. Protect the cylinders from light. Pass 5.0 litres of the test gas into one of the solutions and compare the colour
produced.

The solutions in both cylinders remain colourless.

Water

• Either test A or test B may be applied.

A. The apparatus consists either of an electrolytic hygrometer as described below, an appropriate humidity
detector tube, or a capacity hygrometer.

The measuring cell consists of a thin film of phosphoric anhydride placed between two coiled platinum wires that
act as electrodes. The water vapour in the test gas is absorbed by the phosphoric anhydride to form phosphoric
acid, which acts as an electrical conductor.

Before introducing the test gas into the device, allow the gas to stabilize at room temperature and make sure that
the temperature is constant throughout the apparatus. Apply a continuous voltage across the electrodes to
produce electrolysis of the water and regeneration of phosphoric anhydride. Measure the resulting electrical
current, which is proportional to the water content in the test gas. (This is a self-calibrating system that obeys
Faraday's law.)

Calculate the content of water; not more than 60 μg/l.

B. Determine the content using a water vapour detector tube. Pass the required volume of the test gas through the
tube, the calibration of which is verified according to the manufacturer's instructions.

The gas supply is connected to a pressure regulator and needle valve. Connect the flexible tubing fitted with a Y-
piece to the valve and adjust the flow of the test gas to purge the tubing to an appropriate flow. Fit the water
vapour detector tube to the metering pump following the manufacturer's instructions. Connect the open end of the
tube to the short leg of the tubing and operate the pump sufficiently to pass a suitable volume of the test gas
through the tube. Read the value corresponding to the length of the coloured layer or the intensity of the colour on
the graduated scale; not more than 60 μl/l.

Acidity and alkalinity. Pass 2.0 litres of the test gas through a mixture of 0.10 mL of hydrochloric acid (0.01 mol/l) VS and 50 mL
of carbon-dioxide-free water R.

For reference solution 1, use 50 mL of carbon-dioxide-free water R. For reference solution 2, use a mixture of 0.20 mL of
hydrochloric acid (0.01 mol/l) VS and 50 mL of carbon-dioxide-free water R.

To each solution add 0.1 mL of methyl red/ethanol TS; the intensity of the colour in the solution of the test gas is between those
of reference solutions 1 and 2.

Assay

• Either method A or method B may be applied.

A. For the determination use a 25-mL capacity gas burette (Fig. 8) in the form of a chamber with at its upper end,
a tube graduated in 0.2% between 95 and 100, and isolated at each end by a tap with a conical barrel. The lower
tap is joined to a tube with an olive-shaped nozzle and is used to introduce the test gas into the apparatus. A
cylindrical funnel above the upper tap is used to introduce the absorbent solution. Wash the burette with water and
dry. Open the two taps. Connect the nozzle to the container of the test gas and set the flow rate to 1 litre per
minute. Flush the burette by passing the gas through it for 1 minute. Close the upper tap of the burette and
immediately afterwards the lower tap. Rapidly disconnect the burette from the container of the test gas, and 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 potassium hydroxide (~560 g/l) TS and 130 mL of sodium
dithionite (200 g/l) TS. Open the upper tap slowly. The solution absorbs the oxygen and enters the burette. Allow
to stand for 10 minutes without shaking.

Read the level of the liquid meniscus on the graduated part of the burette; the figure represents the content of
oxygen as a percentage in v/v.

B. Oxygen in medicinal gases can also be determined using a paramagnetic analyser, which measures
electronically the molecule's interaction with magnetic fields.

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The International Pharmacopoeia - Tenth Edition, 2020 Oxygen (Oxygenium)

Figure 8.Burette used for the assay of oxygen

Reproduced with the permission of the European Pharmacopoeia Commission, European Directorate for the Quality of
Medicines, Council of Europe.

Carry out the method according to the instrument manufacturer's instructions.

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