(Ph. Eur. monograph 1307)
Action and use
Excipient.
DEFINITION
Mixture consisting of decyl esters of fatty acids, mainly oleic (cis-9-octadecenoic) acid.
A suitable antioxidant may be added.
CHARACTERS
Appearance
Clear, pale yellow or colourless liquid.
Solubility
Practically insoluble in water, miscible with ethanol (96 per cent), with methylene chloride and with light petroleum (bp: 40-60 °C).
IDENTIFICATION
A. Relative density (see Tests).
B. Saponification value (see Tests).
C. Oleic acid (see Tests).
TESTS
Relative density (2.2.5)
0.860 to 0.870.
Acid value (2.5.1)
Maximum 1.0, determined on 10.0 g.
Iodine value (2.5.4, Method A)
55 to 70.
Peroxide value (2.5.5, Method A)
Maximum 10.0.
Saponification value (2.5.6)
130 to 140, determined on 2.0 g.
Oleic acid (2.4.22, Method A)
Minimum 60.0 per cent in the fatty acid fraction of the substance.
Water (2.5.12)
Maximum 1.0 per cent, determined on 1.00 g.
Total ash (2.4.16)
Maximum 0.1 per cent, determined on 2.0 g.
STORAGE
Protected from light.
