(Ph. Eur. monograph 0899)
C4H8O2 88.1 141-78-6
Action and use
Excipient.
DEFINITION
Ethyl ethanoate.
CHARACTERS
Appearance
Clear, colourless, volatile liquid.
Solubility
Soluble in water, miscible with acetone, with ethanol (96 per cent) and with methylene chloride.
IDENTIFICATION
First identification: B.
Second identification: A, C, D.
A. Boiling point (2.2.12): 76 °C to 78 °C.
B. Infrared absorption spectrophotometry (2.2.24).
Comparison Ph. Eur. reference spectrum of ethyl acetate.
C. It gives the reaction of acetyl (2.3.1).
D. It gives the reaction of esters (2.3.1).
TESTS
Appearance of solution
The solution is clear (2.2.1) and colourless (2.2.2, Method II).
Mix 1 mL of the substance to be examined and 15 mL of water R.
Acidity
To 10 mL of ethanol (96 per cent) R add 0.1 mL of phenolphthalein solution R and 0.01 M sodium hydroxide until the colour changes to pink. Add 5.5 mL of the substance to be examined and 0.25 mL of 0.02 M sodium hydroxide. The solution remains pink for not less than 15 s.
Relative density (2.2.5)
0.898 to 0.902.
Refractive index (2.2.6)
1.370 to 1.373.
Reaction with sulfuric acid
Carefully add 2 mL to 10 mL of sulfuric acid R. After 15 min, the interface between the 2 liquids is not coloured.
Related substances
Gas chromatography (2.2.28).
Test solution The substance to be examined.
Column:
— material: glass;
— size: l = 2 m, Ø = 2 mm;
— stationary phase: ethylvinylbenzene-divinylbenzene copolymer R (136-173 μm).
Carrier gas nitrogen for chromatography R.
Flow rate 30 mL/min.
Temperature:
| Time (min) |
Temperature (°C) |
|
| Column | 0 – 18.8 | 90 → 240 |
| 18.8 – 26.8 | 240 | |
| Injection port | 240 | |
| Detector | 240 |
Limit:
— total: not more than 0.2 per cent of the area of the principal peak.
Residue on evaporation
Maximum 30 ppm.
Evaporate 100.0 g to dryness on a water-bath and dry in an oven at 100-105 °C. The residue weighs not more than 3 mg.
Water (2.5.12)
Maximum 0.1 per cent, determined on 10.0 mL.
STORAGE
Protected from light, at a temperature not exceeding 30 °C.
IMPURITIES

A. methyl ethanoate (methyl acetate),

B. ethanol,







