EUROPEAN PHARMACOPOEIA 6.0 2.9.10. Ethanol content and alcoholimetric tables 032+ m le ers Figure 2.9.9-3— Microcone (m = 7.0 9) suitable container and shaft 1 = 116 mma: m = 168 9) Dimensions in mittimetres 01/2008:20910 2.9.10. ETHANOL CONTENT AND. ALCOHOLIMETRIC TABLES ‘This method is intended only for the examination of liquid pharmaceutical preparations containing ethanol. These preparations also contain dissolved substances which ‘ust be separated from the ethanol to be determined by disilation. When distillation would distil volatile substances ‘other than ethanol and water the appropriate precautions are stated in the monograph, ‘The ethanol content ofa liquid is expressed as the number of yolumes of ethanol contained in 100 volumes of the liu, the volumes being measured at 20 + 0.1 °C. This is known as the “percentage of ethanol by volume” (per cent V1. The ‘content may also be expressed in grams of ethanol per 100 of the liquid. This is known as the “percentage of cthanol by mass” (per cent mn) The relation between the density at 20 + 0.1 °C, the relative density (corrected to vacuum) and the ethanol content of a mixture of water and ethanol is given in the tables of the International Organisation for Legal Metvology (1972), International Recommendation No. 22 Apparatus. The apparatus (see Figure 2.9.10-1) consists ofa round-bottomed flask (A) fitted with a distillation head (B) with a steam trap and attached to a vertical condenser (C). ‘The later is fitted at its lower part with a tube (D) which carries the distillate into the lower part of a 100 mil or 250 ml volumetric flask. The volumetric flask is immersed in a mixture of ice and water (E) during the distillation. A dise having cireular aperture 6 cm in diameter is placed under flask (A) to reduce the tisk of chanting of any dissolved substances, Method Pycnometer method. Transfer 25.0 ml of the preparation to be examined, measured at 20 + 0.1 °C, to the distillation flask. Dilute with 100 ml to 150 ml of distilled water R and adda few pieces of pumice. Attach the disillation head and condenser. Distil and collect not less than 90 ml of distillate ina 100 ml volumetric flask. Adiust the temperature to 2020.1 °Cand dilute to 100.0 ml with distilled water Rat 20 +0.1 °C. Determine the relative density at 20 + 0.1 °C uusinga pyenometer Table 2.9.10-1. « Relationship between density, relative density and ethanol content Pe elalvedensty ofthe ‘Ethanol coatent a Gear) atelate measured In alt per cent VA" a0 9685 950.0 sos2.9.11. Test for methanol and 2-propanol EUROPEAN PHARMACOPOEIA 6.0 Relative deaslty ofthe Asullte measured ln ale vat nar nas ne 1060 mos 985.0 276 oss 938 seco ea sees ast azo ry 9875 a3 980 7 ose 695 9sn0 656 9888 sir 9900 579 9905; sae eoL0 sob sas ast 920 420 90s aa a0 was 94.0 ons 2a 980 216 98 09973 ase 9960 09ers at 9965 09983 Ls eon0 0998s 280 ous 9903 cas sao 9908 ots ‘The values indicated in Table 2.9.10-1, column 3, are multiplied by four to obtain the percentage of ethanol by volume (1/1) contained in the preparation. After calculation, ofthe ethanol content using the Table, round off the result to one decimal place, Hydrometer method. Transfer 50.0 ml of the preparation to be examined, measured at 20 + 0.1 °C, to the distillation flask, add 200 ml to 300 ml of distilted water R and distil, as, described above, into a volumetric flask until at least 180 ml has been collected. Adjust the temperature to 20 + 0.1 °C and dilute to 250.0 ml with distilled water Rat 200.1 °C. ‘Transfer the distillate toa eylinder whose diameter is at last 6 mm wider than the bulb of the bydvometer. Ifthe volume is, insufficient, dauble the quantity of the sample and dilute the distillate to'500.0 ml with distilled wazer Rat 20 + 0.1 °C. Multiply the strength by five to allow for the dilution during the determination. After calculation of the ethanol content using the Table 2.9.10-1 round off the result to one decimal phe. Figure 2.9.10-1. ~ Apparatus for the determination of ethanol content Dimensions in millimetres 01/200: 2.9.11. TEST FOR METHANOL AND 2-PROPANOL Examine by gas chromatography (2.2.28) Internal standard solution. Prepare a solution containing 255 per cent VV of propanol R in ethanol RI. Test solution (a). To a certain amount of the distillate add 2.0:ml of the internal standard solution; adjust the ethanol content (2.9.16) to 10.0 per cent V/V’ by dilution to 50 ml with water R ot addition of ethanol RI.