EUROPEAN PHARMACOPOEIA 8.

0 Oxygen

Mobile phase :
mobile phase A : mix 830 mL of a 1.1 g/L solution of sodium
heptanesulfonate monohydrate R previously adjusted to
pH 2.0 with a mixture of equal volumes of phosphoric
acid R and water R, with 70 mL of acetonitrile R and
100 mL of methanol R ;
mobile phase B : mix 600 mL of a 1.1 g/L solution of sodium A. R1 = H, R2 = R3 = O, R4 = CH3 : 4,5-epoxy-3,14-
heptanesulfonate monohydrate R previously adjusted to dihydroxy-17-methylmorphinan-6-one (oxymorphone),
pH 2.0 with a mixture of equal volumes of phosphoric
acid R and water R, with 150 mL of acetonitrile R and B. R1 = R4 = CH3, R2 = OH, R3 = H : 4,5-epoxy-
250 mL of methanol R ; 3-methoxy-17-methylmorphinan-6,14-diol
(7,8-dihydro-14-hydroxycodeine),
Time Mobile phase A Mobile phase B
C. R1 = CH3, R2 + R3 = O, R4 = H : 4,5-epoxy-14-hydroxy-
(min) (per cent V/V) (per cent V/V)
3-methoxymorphinan-6-one (noroxycodone),
0 - 60 100 50 0 50

Flow rate : 1.5 mL/min.

Detection : spectrophotometer at 230 nm.
Injection : 20 L.
Relative retention with reference to oxycodone (retention
time = about 24 min): impurity A = about 0.4 ;
impurity B = about 0.7 ; impurity C = about 1.14 ; D. 7,8-didehydro-4,5-epoxy-14-hydroxy-3-methoxy-17-
impurity D = about 1.18 ; impurity E = about 1.18 ; methylmorphinan-6-one (14-hydroxycodeinone),
impurity F = about 2.4.
System suitability : reference solution (b) :
resolution : minimum 3 between the peaks due to oxycodone
and impurity D.
Limits :
correction factor : for the calculation of content, multiply
the peak area of impurity F by 0.5 ; E. 4,5-epoxy-3-methoxy-17-methylmorphinan-6-one
(hydrocodone),
sum of impurities D and E : not more than 10 times the
area of the peak due to oxycodone in the chromatogram
obtained with reference solution (b) (1.0 per cent) ;
impurities A, B, C, F : for each impurity, not more than the
area of the peak due to oxycodone in the chromatogram
obtained with reference solution (b) (0.1 per cent) ;
any other impurity : for each impurity, not more than the
area of the peak due to oxycodone in the chromatogram F. 6,7,8,14-tetradehydro-4,5-epoxy-3-6-dimethoxy-17-
obtained with reference solution (b) (0.1 per cent) ; methylmorphinan (thebain).
total : not more than 15 times the area of the peak due to
oxycodone in the chromatogram obtained with reference 01/2010:0417
solution (b) (1.5 per cent) ;
disregard limit : 0.5 times the area of the peak due to OXYGEN
oxycodone in the chromatogram obtained with reference
solution (b) (0.05 per cent). Oxygenium
Ethanol (2.4.24, System A): maximum 1.0 per cent.
O2 Mr 32.00
Water (2.5.12) : maximum 7.0 per cent, determined on 0.250 g. [7782-44-7]
Sulfated ash (2.4.14) : maximum 0.1 per cent, determined on
1.0 g. DEFINITION
Content : minimum 99.5 per cent V/V of O2.
ASSAY This monograph applies to oxygen for medicinal use.
Dissolve 0.250 g in a mixture of 5.0 mL of 0.01 M hydrochloric CHARACTERS
acid and 60 mL of ethanol (96 per cent) R. Titrate with 0.1 M
Appearance : colourless gas.
ethanolic sodium hydroxide, determining the end-point
potentiometrically (2.2.20). Measure the volume used between Solubility : at 20 C and at a pressure of 101 kPa, 1 volume
the 2 inexion points. dissolves in about 32 volumes of water.
1 mL of 0.1 M ethanolic sodium hydroxide is equivalent to PRODUCTION
35.19 mg of C18H22ClNO4. Oxygen is produced by a purication process followed by
cryodistillation of the ambient air.
STORAGE
Carbon dioxide : maximum 300 ppm V/V, determined using
In an airtight container, protected from light. an infrared analyser (2.5.24).
Gas to be examined. Filter the substance to be examined to
IMPURITIES avoid stray light phenomena.
Specified impurities : A, B, C, D, E, F. Reference gas (a). Oxygen R.

General Notices (1) apply to all monographs and other texts 2941
Oxygen (93 per cent)
Reference gas (b). Mixture containing 300 ppm V/V of carbon
dioxide R1 in nitrogen R1.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of carbon dioxide in
the gas to be examined.
Carbon monoxide : maximum 5 ppm V/V, determined using
an infrared analyser (2.5.25).
Gas to be examined. Filter the substance to be examined to
avoid stray light phenomena.
Reference gas (a). Oxygen R.
Reference gas (b). Mixture containing 5 ppm V/V of carbon
monoxide R in nitrogen R1.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of carbon monoxide in
the gas to be examined.
Water: maximum 67 ppm V/V, determined using an
electrolytic hygrometer (2.5.28).
Assay. Determine the concentration of oxygen using a
paramagnetic analyser (2.5.27).
IDENTIFICATION
It complies with the limits of the assay.
TESTS
Carbon dioxide : maximum 300 ppm V/V, determined using
a carbon 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).
STORAGE
As a compressed gas or liquid in appropriate containers,
complying with the legal regulations. Oils and grease are not
to be used unless they are oxygen-compatible.
IMPURITIES
Specified impurities : A, B, C.
A. CO2 : carbon dioxide,
B. CO : carbon monoxide,
C. H2O : water.
04/2011:2455
OXYGEN (93 PER CENT)
Oxygenium 93 per centum
O2 Mr 32.00
DEFINITION
Content : 90.0 per cent V/V to 96.0 per cent V/V of O2, the
remainder mainly consisting of argon and nitrogen.
This monograph applies to oxygen (93 per cent) for medicinal
use. It does not apply to gas produced using individual
concentrators for domiciliary use.
PRODUCTION
Oxygen (93 per cent) is produced in single-stage concentrators
by adsorption purication of ambient air using zeolites.
During production, the oxygen content is continuously
monitored by means of a paramagnetic analyser (2.5.27).
Following the design and installation of the concentrator, and
after any modication or signicant intervention, the gas
produced complies with the following requirements.
2942
EUROPEAN PHARMACOPOEIA 8.0
Carbon dioxide : maximum 300 ppm V/V, determined using
an infrared analyser (2.5.24).
Gas to be examined. The substance to be examined. It must be
ltered to avoid stray light phenomena.
Reference gas (a). Oxygen R.
Reference gas (b). A mixture of 7 per cent V/V of nitrogen R1
and 93 per cent V/V of oxygen R, containing 300 ppm V/V
of carbon dioxide R1.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of carbon dioxide in
the gas to be examined.
Carbon monoxide : maximum 5 ppm V/V, determined using
an infrared analyser (2.5.25).
Gas to be examined. The substance to be examined. It must be
ltered to avoid stray light phenomena.
Reference gas (a). Oxygen R.
Reference gas (b). A mixture containing 5 ppm V/V of carbon
monoxide R in nitrogen R1.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of carbon monoxide in
the gas to be examined.
Nitrogen monoxide and nitrogen dioxide : maximum
2 ppm V/V in total, determined using a chemiluminescence
analyser (2.5.26).
Gas to be examined. The substance to be examined.
Reference gas (a). A mixture of 21 per cent V/V of oxygen R
and 79 per cent V/V of nitrogen R1, containing less than
0.05 ppm V/V of nitrogen monoxide and nitrogen dioxide.
Reference gas (b). A mixture containing 2 ppm V/V of nitrogen
dioxide R in nitrogen R1.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of nitrogen monoxide
and nitrogen dioxide in the gas to be examined.
Sulfur dioxide : maximum 1 ppm V/V, determined using an
ultraviolet uorescence analyser (Figure 2455.-1.).
The apparatus consists of the following :
a system generating ultraviolet radiation with a wavelength
of 210 nm, made up of an ultraviolet lamp, a collimator,
and a selective lter ; the beam is blocked periodically by a
chopper rotating at high speeds ;
a reaction chamber, through which ows the gas to be
examined ;
a system that detects radiation emitted at a wavelength of
350 nm, made up of a selective lter, a photomultiplier
tube and an amplier.
Gas to be examined. The substance to be examined. It must
be ltered.
Reference gas (a). A mixture of 7 per cent V/V of nitrogen R1
and 93 per cent V/V of oxygen R.
Reference gas (b). A mixture of 7 per cent V/V of nitrogen R1
and 93 per cent V/V of oxygen R, containing 0.5 ppm V/V to
2 ppm V/V of sulfur dioxide R1.
Calibrate the apparatus and set the sensitivity using reference
gases (a) and (b). Measure the content of sulfur dioxide in
the gas to be examined.
Oil : maximum 0.1 mg/m3, determined using an oil detector
tube (2.1.6).
Water : maximum 67 ppm V/V, determined using an
electrolytic hygrometer (2.5.28).
Assay. Determine the concentration of oxygen using a
paramagnetic analyser (2.5.27).
CHARACTERS
Appearance : colourless gas.
IDENTIFICATION
It complies with the limits of the assay.
See the information section on general monographs (cover pages)