• British Pharmacopoeia Volume I & II
  • Monographs: Medicinal and Pharmaceutical Substances

Cocoyl Caprylocaprate

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General Notices

(Ph. Eur. monograph 1411)

Action and use

Excipient.

Ph Eur

DEFINITION

Mixture of esters of saturated C12 - C18 alcohols with caprylic (octanoic) and capric (decanoic) acids obtained by the reaction of these acids with vegetable saturated fatty alcohols.

CHARACTERS
Appearance

Slightly yellowish liquid.

Solubility

Practically insoluble in water, miscible with ethanol (96 per cent) and with liquid paraffin.

Relative density

About 0.86.

Refractive index

About 1.445.

Viscosity

About 11 mPa·s.

IDENTIFICATION

A. Freezing point (2.2.18): maximum 15 °C.

B. Infrared absorption spectrophotometry (2.2.24).

Comparison   cocoyl caprylocaprate CRS.

C. Composition of fatty acids and fatty alcohols (see Tests).

TESTS
Appearance

The substance to be examined is not more intensely coloured than reference solution Y5 (2.2.2, Method I).

Acid value (2.5.1)

Maximum 0.5, determined on 5.00 g.

Hydroxyl value (2.5.3, Method A)

Maximum 5.0.

Iodine value (2.5.4, Method A)

Maximum 1.0.

Saponification value (2.5.6)

160 to 173.

Composition of fatty acids and fatty alcohols (2.4.22, Method C)

Use the chromatogram obtained with the following reference solution for identification of the peaks due to the fatty alcohols.

Reference solution  Dissolve the amounts of the substances listed in the following table in 10 mL of heptane R.

bp2013_v1_07_medicinal_and_pharmaceutical_substances_05 cocoylcaprylocaprate_1_2012_70_tb.png


Consider the sum of the areas of the peaks due to the fatty acids listed below to be equal to 100 and the sum of the areas of the peaks due to the fatty alcohols listed below to be equal to 100.

Composition of the fatty acid fraction of the substance:
  • capric acid: 20.0 per cent to 50.0 per cent,
Composition of the fatty alcohol fraction of the substance:
  • capric alcohol: maximum 3.0 per cent,
  • lauryl alcohol: 48.0 per cent to 63.0 per cent,
  • myristyl alcohol: 18.0 per cent to 27.0 per cent,
  • stearyl alcohol: 9.0 per cent to 16.0 per cent.
Water (2.5.12)

Maximum 0.1 per cent, determined on 5.00 g.

Total ash (2.4.16)

Maximum 0.1 per cent, determined on 1.0 g.

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