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Print Preview EUROPEAN PHARMACOPOEIA 6.0 Ether 01/2008:0650 ETHER G. butan-2-one (methyl ethyl ketone), Aether H. 4-methylpentan-2-one (methyl isobutyl ketone), C4H10O Mr 74.1 I. CH3-(CH2)2-OH: propanol, [60-29-7] J. propan-2-ol (isopropyl alcohol), DEFINITION K. CH3-(CH2)3-OH: butanol, Diethyl ether. It may contain a suitable non-volatile antioxidant at a suitable concentration. CHARACTERS L. butan-2-ol, Appearance: clear, colourless liquid, volatile. Solubility: soluble in water, miscible with ethanol (96 per cent), with methylene chloride and with fatty oils. It is highly flammable. M. 2-methylpropanol (isobutanol), IDENTIFICATION A. Relative density (see Tests). B. Distillation range (see Tests). TESTS N. furane-2-carbaldehyde (furfural), Acidity.To20mlofethanol (96 per cent) R add 0.25 ml of bromothymol blue solution R1 and, dropwise, 0.02 M sodium hydroxide until a blue colour persists for 30 s. Add 25 ml of the substance to be examined, shake and add, dropwise, 0.02 M sodium hydroxide until the blue colour O. 2-methylpropan-2-ol (1,1-dimethylethyl alcohol), reappears and persists for 30 s. Not more than 0.4 ml of 0.02 M sodium hydroxide is required. Relative density (2.2.5) : 0.714 to 0.716. Distillation range (2.2.11). Do not distil if the substance to be examined does not comply with the test for peroxides.It P. 2-methylbutan-2-ol, distils completely between 34.0 °C and 35.0 °C. Carry out thetestusingasuitableheatingdeviceandtakingcareto avoid directly heating the flask above the level of the liquid. Aldehydes. To 10.0 ml in a ground-glass-stoppered cylinder add 1 ml of alkaline potassium tetraiodomercurate Q. pentan-2-ol, solution R and shake for 10 s. Allow to stand for 5 min, protected from light. The lower layer may show a yellow R. CH3-(CH2)4-OH: pentanol, or reddish-brown opalescence but not a grey or black opalescence. S. CH3-(CH2)5-OH: hexanol, Peroxides.Place8mlofpotassium iodide and starch solution R in a 12 ml ground-glass-stoppered cylinder about 15 mm in diameter. Fill completely with the substance to be examined, mix and allow to stand protected from light for 5 min. No colour develops. T. heptan-2-ol, Non-volatile matter:maximum20mg/l. After ensuring that the substance to be examined complies with the test for peroxides, evaporate 50 ml to dryness on awater-bathanddrytheresidueinanovenat100-105°C. U. hexan-2-ol, The residue weighs a maximum of 1 mg. Substances with a foreign odour. Moisten a disc of filter paper 80 mm in diameter with 5 ml of the substance to be examined and allow to evaporate. No foreign odour is perceptible immediately after the evaporation. V. hexan-3-ol. Water (2.5.12): maximum 2 g/l, determined on 20 ml. GeneralNotices(1)applytoallmonographsandothertexts 1833 Ether, anaesthetic EUROPEAN PHARMACOPOEIA 6.0 STORAGE Substances with a foreign odour. Moisten a disc of filter In an airtight container, protected from light, at a paper 80 mm in diameter with 5 ml of the substance to temperature of 8 °C to 15 °C. be examined and allow to evaporate. No foreign odour is perceptible immediately after the evaporation. Water (2.5.12): maximum 2 g/l, determined on 20 ml. 01/2008:0367 STORAGE ETHER, ANAESTHETIC In an airtight container, protected from light, at a temperature of 8 °C to 15 °C. The contents of a partly filled Aether anaestheticus container may deteriorate rapidly. 01/2008:0140 C4H10O Mr 74.1 corrected 6.0 [60-29-7] DEFINITION ETHINYLESTRADIOL Diethyl ether. It may contain a suitable non-volatile antioxidant at an Ethinylestradiolum appropriate concentration. CHARACTERS Appearance: clear, colourless liquid, volatile, very mobile. Solubility: soluble in 15 parts of water, miscible with ethanol (96 per cent) and with fatty oils. It is highly flammable. IDENTIFICATION C20H24O2 Mr 296.4 A. Relative density (see Tests). [57-63-6] B.Distillationrange(seeTests). DEFINITION TESTS 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Acidity.To20mlofethanol (96 per cent) R add 0.25 ml Content: 97.0 per cent to 102.0 per cent (dried substance). of bromothymol blue solution R1 and, dropwise, 0.02 M sodium hydroxide until a blue colour persists for 30 s. Add CHARACTERS 25 ml of the substance to be examined, shake and add, Appearance: white or slightly yellowish-white, crystalline dropwise, 0.02 M sodium hydroxide until the blue colour powder. reappears and persists for 30 s. Not more than 0.4 ml of Solubility: practically insoluble in water, freely soluble in 0.02 M sodium hydroxide is required. alcohol. It dissolves in dilute alkaline solutions. Relative density (2.2.5): 0.714to0.716. IDENTIFICATION Distillation range (2.2.11). Do not distil if the substance to be examined does not comply with the test for peroxides.It A. Infrared absorption spectrophotometry (2.2.24). distils completely between 34.0 °C and 35.0 °C. Carry out Comparison: ethinylestradiol CRS. the test using a suitable heating device and taking care to If the spectra obtained in the solid state show differences, avoid directly heating the flask above the level of the liquid. dissolvethesubstancetobeexaminedandthereference Acetone and aldehydes. To 10.0 ml in a ground-glass- substance in methanol R, evaporate to dryness and stoppered cylinder add 1 ml of alkaline potassium record new spectra using the residues. tetra-iodomercurate solution R and shake for 10 s. Allow to B. Thin-layer chromatography (2.2.27). stand for 5 min, protected from light. The lower layer shows Test solution. Dissolve 25 mg of the substance to be only a slight opalescence. examined in a mixture of 1 volume of methanol R and If the substance to be examined does not comply with the 9volumesofmethylenechlorideRand dilute to 25 ml test, distil 40 ml, after ensuring that the substance to be with the same mixture of solvents. examined complies with the test for peroxides,untilonly Reference solution. Dissolve 25 mg of ethinylestradi- 5 ml remains. Collect the distillate in a receiver cooled in a ol CRS in a mixture of 1 volume of methanol R and bath of iced water and repeat the test described above using 9volumesofmethylenechlorideRand dilute to 25 ml 10.0 ml of the distillate. with the same mixture of solvents. Peroxides.Place8mlofpotassium iodide and starch Plate: TLC silica gel G plate R. solution R in a 12 ml ground-glass-stoppered cylinder about 15 mm in diameter. Fill completely with the substance to be Mobile phase: alcohol R, toluene R (10:90 V/V). examined, shake vigorously and allow to stand protected Application:5µl. from light for 30 min. No colour develops. Development:overapathof15cm. Non-volatile matter:maximum20mg/l. Drying: in air until the solvent has evaporated. After ensuring that the substance to be examined complies Detection: heat at 110 °C for 10 min, spray the hot plate with the test for peroxides, evaporate 50 ml to dryness on with alcoholic solution of sulphuric acid R and heat a water-bath and dry the residue in an oven at 100-105 °C. again at 110 °C for 10 min. Examine in daylight and in The residue weighs a maximum of 1 mg. ultraviolet light at 365 nm. 1834 See the information section on general monographs (cover pages).
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