Ph Eur
Action and use: Excipient.
DEFINITION
Condensation product of saturated liquid fatty alcohols.
Content: Minimum 90 per cent of (2RS)-2-octyldodecan-1-ol (C20H42O; Mr 298.6), the remainder consisting mainly of related alcohols.
CHARACTERS
Appearance: Clear, colourless or yellowish, oily liquid.
Solubility: Practically insoluble in water, miscible with ethanol (96 per cent).
Relative density: About 0.840.
Refractive index: About 1.455.
IDENTIFICATION
A. Hydroxyl value (see Tests).
B. Thin-layer chromatography.
TESTS
Acidity or alkalinity: Mix 5.0 g thoroughly for 1 min with a mixture of 0.1 ml of bromothymol blue solution, 2 ml of heptane and 10 ml of water. If the aqueous layer is blue, not more than 0.15 ml of 0.01 M hydrochloric acid is required to change the colour of the indicator to yellow. If the aqueous layer is yellow, add 0.45 ml of 0.01 M sodium hydroxide and shake vigorously. After standing to ensure complete separation, the aqueous layer is blue.
Optical rotation: - 0.10° to + 0.10°.
Hydroxyl value: 175 to 190.
Iodine value: Maximum 8.0.
Peroxide value: Maximum 5.0.
Saponification value: Maximum 5.0.
Heavy metals: Maximum 10 ppm.
Water: Maximum 0.5 per cent, determined on 2.00 g.
Sulphated ash: Maximum 0.1 per cent, determined on 1.0 g.
ASSAY: By Gas chromatography
Octyldodecanol contains not less than 90.0 percent of 2-octyldodecanol, the remainder consisting chiefly of related alcohols.
Identification: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the major peak in the chromatogram of the System suitability solution, as obtained in the Assay.
Acid value: not more than 0.5.
Iodine value: not more than 8.
Hydroxyl value: between 175 and 190.
Saponification value: not more than 5.
For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.
