1238E.htm Pagina 1 de 6 01/2009:1238 AIR, MEDICINAL Aer medicinalis DEFINITION ‘Compressed ambient air. Content 20.4 per cent V/V to 21.4 per cent V/V of oxygen (O,), CHARACTERS: Appearance: colourless gas. ‘Solubility. at 20 °C at a pressure of 101 kPa, 1 volume dissolves in about 50 volumes of water. PRODUCTION Carbon dioxide: maximum 500 ppm V/V, determined using an infrared analyser (2.5.24). Gas to be examined. Filter the substance to be examined to avoid stray light phenomena Reference gas (a). Use a mixture of 21 per cent V/V of oxvaen R and 79 per cent V/V of nitrogen 1, containing less than 1 ppm V/V of carbon dioxide R1 Reference gas (b). Use a mixture of 21 per cent V/V of oxygen R and 79 per cent V/V of nitrogen R41, containing 500 ppm V/V of carbon dioxide Ri. 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 (2.5.26). Gas to be examined. Filter the substance to be examined to avoid stray light phenomena Reference gas (a). Use a mixture of 21 per cent V/V of oxygen R and 79 per cent V/V of nitrogen Rt containing less than 1 ppm V/V of carbon monoxide R. Reference gas (b). Use a mixture of 21 per cent V/V of oxvaen 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 the gas to be examined. Sulfur dioxide: maximum 1 ppm V/V, determined using an ultraviolet fluorescence analyser (Figure 1238.-1), http://127.0.0.1:58054/NetisUtils/srvrutil_getdoc.aspx/0L34qCJ8uE3bSCI8pE4KKQ7... 22/11/20171238E.htm Pagina 2 de 6 ~<——— Chopper ‘Sample in ‘Sample out y iH oe ee Giz ae —_—> “P | Cc) <—\ Fitter 350 nm UV Source Filter 210 nm Collimator Poa Photomultiplier Amplifier Figure 1238.-1. - UV fluorescence analyser The apparatus consists of the following — a system generating ultraviolet radiation with @ wavelength of 210 nm, made up of an ultraviolet lamp, @ collimator, and a selective filter; the beam is blocked periodically by a chopper rotating at high speeds; = a reaction chamber, through which flows the gas to be examined; — a system that detects radiation emitted at a wavelength of 350 nm, made up of a selective fier, a photomultiplier tube and an amplifier. Gas to be examined. Filter the substance to be examined. Reference gas (a). Use a mixture of 21 per cent V/V of oxvaen R and 79 per cent V/V of nitrogen R1 Reference gas (b). Use a mixture of 21 per cent V/V of oxvaen R and 79 per cent V/V of nitrogen R1 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/m, determined using an oil detector tube (2.1.6), when an oll-ubricated compressor is used for the production. Nitrogen monoxide and nitrogen dioxide: maximum 2 ppm V/V in total, determined using @ ‘chemiluminescence analyser (2.5.26) Gas to be examined. The substance to be examined. Reference gas (a). Use a mixture of 21 per cent V/V of oxvgen R and 79 per cent V/V of nitrogen Rt, containing less than 0.05 ppm V/V of nitrogen monoxide and nitrogen dioxide. Reference gas (b). Use a mixture of 2 ppm V/V of nitrogen monoxide R in nitrogen R41 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. Water: maximum 67 ppm V/V, determined using an electrolytic hygrometer (2.5.26), except where the teeem://197 01) 1-S80$4/Net; Jeryruti] vetdoc.aspx/0L34qCJ8uE3bSCI8pE4KkQ7... 22/11/20171238E.htm Pagina 3 de 6 competent authority decides that the following limit applies to medicinal air generated on-site and distributed in pipe-tine 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 (2.5.26). Assay. Determine the concentration of oxygen in air using a paramagnetic analyser (2.5.27). IDENTIFICATION First identification: C. ‘Second identification: A, B. ‘A. Ina conical flask containing the substance to be examined, place a glowing wood splinter. The splinter remains glowing. B. Use a gas burette (Figure 1238.-2) of 25 mL capacity in 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 olive-shaped nozzle and is used to introduce the gas into 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 {928 to be examined and set the flow rate to 1 Limin. 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, fil the funnel with a freshly prepared mixture of 21 mL of a §60 g/L solution of potassium hydroxide R and 130 mL of @ 200 g/L solution ‘of sodium dithionite R. Open the upper tap siowly. 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. . It complies with the limits of the assay. 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 mgim?, determined using an oil detector tube (2.1.5), when an oil-ubricated 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 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 § °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 @ pipe network. LABELLING ‘Where applicable, the label states the production method, as regards to the use of an cil - lubricated compression. IMPURITIES ‘A. CO, carbon dioxide, aeee-//197 010) 1-S8054/Neticl Itile/ervrutil getdoc.aspx/0L34qCJ8uE3bSCISpE4KkQ7... 22/11/2017