Note: These are edited, condensed versions of the standards. For further information on specific test procedures, reference should be made to the Pharmacopoeia of Japan, published by the Society of Japanese Pharmacopoeia.
1. Ethanol (Alcohol)
| (a) | Definition: | Contains not less than 95.1% v/v, and not more than 95.6% v/v of ethanol at 15°C. | |
| (b) | Description: | Clear, colorless, volatile liquid. It has a characteristic odor and burning taste. It is miscible with water, and with ether. It is flammable, and burns with a light-blue flame, on ignition. | |
| (c) | Identification: | (1)
When 1 ml of ethanol is mixed with 2 ml of iodine and sodium hydroxide solution,
a light-yellow precipitate is produced. (2) When 1 ml of ethanol is heated with 1 ml of glacial acetic acid and 3 drops of sulphuric acid, the characteristic odor of ethyl acetate should be perceptible. |
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| (d) | Specific gravity at 15°C: | 0.814 to 0.816 | |
| (e) | Purity: | ||
| (1) | Clarity of solution: | When 10 ml of ethanol are mixed with 30 ml of water, and allowed to stand for 30 minutes at 5 - 10°C, the mixture should remain clear. | |
| (2) | Acidity or alkalinity: | When 20 ml of freshly-boiled-and-cooled water, and 3 drops of phenolphthalein are added to 20 ml of ethanol, no color should develop. Then, when 0.1 ml of 0.1 N sodium hydroxide are added, a red color should develop. | |
| (3) | Chlorides: | When 2 drops of dilute nitric acid and 2 drops of silver nitrate solution are added to 10 ml of ethanol, and then it is allowed to stand for 5 minutes, the solution should remain unchanged. | |
| (4) | Heavy metals: | Conduct the standard test according to Method 1, using 30 ml of ethanol, using a standard containing 3 ml of standard lead solution (not more than 1.2 ppm). | |
| (5) | Fusel-oil constituents: | (a)
When 10 ml of ethanol is mixed with 5 ml of water and 1 ml of glycerin,
and 0.3 ml of the mixture is put on odorless filter paper; no foreign odor
should remain after the mixture has volatilized at room temperature. (b) When 5 ml of ethanol are carefully superimposed on 5 ml of sulphuric acid in a test tube, no red color should develop at the interface. |
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| (6) | Aldehydes and other foreign reducing substances: | (a)
When 0.3 ml of 0.1 N potassium permanganate solution are added to 10 ml
of ethanol at 15°C and the mixture is allowed to stand for 20 minutes,
the red color should remain visible. (b) When 5 ml of sodium hydroxide solution are added to 10 ml of ethanol, and the mixture is allowed to stand for 5 minutes, no yellow color should develop. |
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| (7) | Ketones, isopropanol and tertiary butanol: | The ethanol should meet the requirements of the standard test. | |
| (8) | Methanol: | The ethanol should meet the requirements of the standard test. | |
| (9) | Residue on evaporation: | When 40 ml of ethanol are evaporated in a tared dish on a waterbath, and then dried for 1 hour at 105°C, the weight of the residue should not exceed 1.0 mg. | |
2. Dehydrated Ethanol (Absolute or anhydrous ethanol)
| (a) | Definition: | Contains not less than 99.5% v/v ethanol at 15°C. | |
| (b) | Description: | Clear, colorless, volatile liquid, having a characteristic odor and burning taste. It is miscible with water and with ether. It is flammable, and burns with a light-blue flame on ignition. Boiling point 78 - 79°C. | |
| (c) | Identification: | Complies with the requirements described for "Ethanol." | |
| (d) | Specific gravity at 15°C: | Not more than 0.797 | |
| (e) | Purity: | Complies with the requirements described for "Ethanol." | |