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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) EUROPEAN PHARMACOPOEIA 8.0

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

2942 See the information section on general monographs (cover pages)