DEFINITION
Olive Oil Ear Drops are Virgin Olive Oil in a suitable container.
The ear drops comply with the requirements stated under Ear Preparations and with the following requirements.
IDENTIFICATION
Carry out the test for the identification of fatty oils by thin-layer chromatography, Appendix X N. The chromatogram obtained from the oil being examined shows spots corresponding to those in the typical chromatogram for olive oil. For certain types of olive oil the difference in the sizes of spots E and F is less pronounced than in the figure.
TESTS
Acid value
Not more than 2.0, Appendix X B. Use 5 g.
Light absorption
The absorbance of a 1% w/v solution in cyclohexane at the maximum at 270 nm is not more than 0.20, Appendix II B. The ratio of the absorbance at 232 nm to that at 270 nm is greater than 8.
Peroxide value
Not more than 20.0, Appendix X F.
Relative density
0.910 to 0.916, Appendix V G.
Unsaponifiable matter
Not more than 1.5% w/w when determined by the following method. To 5 g of the oil in a 150-mL flask add 50 mL of 2M ethanolic potassium hydroxide and heat under a reflux condenser on a water bath for 1 hour, shaking frequently. Add 50 mL of water through the condenser, shake, allow to cool and transfer the contents of the flask to a separating funnel, rinsing the flask with 50 mL of petroleum spirit (boiling range, 40° to 60°) in portions and adding the rinsings to the separating funnel. Shake vigorously for 1 minute, allow to separate and transfer the aqueous layer to a second separating funnel. If an emulsion forms add small quantities of ethanol (96%) or a concentrated solution of potassium hydroxide. Extract the aqueous layer with two 50-mL quantities of petroleum spirit (boiling range, 40° to 60°) and combine the organic layers in a third separating funnel. Wash with three 50-mL quantities of ethanol (50%), transfer the petroleum spirit layer to a weighed 250-mL flask, rinse the separating funnel with small quantities of petroleum spirit (boiling range, 40° to 60°) and add the rinsings to the flask. Evaporate the solvent on a water bath, dry at 100° to 105° for 15 minutes with the flask in a horizontal position, allow to cool and weigh. Repeat the drying for successive 15-minute periods until the loss in weight between two successive weighings does not exceed 0.1%. Dissolve the residue in 20 mL of ethanol (96%) previously neutralised to 0.1 mL of bromophenol blue solution and, if necessary, titrate with 0.1M hydrochloric acid VS. Calculate the percentage content of unsaponifiable matter from the expression:
100(a-0.032b)/w
where a is the weight, in g, of the residue, b is the volume, in mL, of 0.1M hydrochloric acid VS required and w is the weight, in g, of oil taken. The test is not valid if 0.032b is greater than 5% of a and must be repeated.
Foreign fixed oils
Carry out the test for composition of fatty acids by gas chromatography, Appendix X N. The fatty-acid fraction of the oil has the following composition.
Saturated fatty acids of chain length less than C16: Not more than 0.1%.
Palmitic acid: 7.5 to 20.0%.
Palmitoleic acid (equivalent chain length on polyethylene glycol adipate, 16.3): Not more than 3.5%.
Stearic acid: 0.5 to 5.0%.
Oleic acid (equivalent chain length on polyethylene glycol adipate, 18.3): 56.0 to 85.0%.
Linoleic acid (equivalent chain length on polyethylene glycol adipate, 18.9): 3.5 to 20.0%.
Linolenic acid (equivalent chain length on polyethylene glycol adipate, 19.7): Not more than 1.2%.
Arachidic acid: Not more than 0.7%.
Eicosenoic acid (equivalent chain length on polyethylene glycol adipate, 20.3): Not more than 0.4%.
Behenic acid: Not more than 0.2%.
Lignoceric acid: Not more than 0.2%.
Sterols
Carry out the test for the determination of sterols, Appendix X N. The sterol fraction of the oil has the following composition:
sum of contents of β-sitosterol, Δ5,23-stigmastadienol, clerosterol, sitostanol, Δ5-avenasterol and Δ5,24-stigmastadienol: not less than 93.0%.
cholesterol: not more than 0.5%.
Δ7-stigmasterol: not more than 0.5%.
campesterol: not more than 4.0%.
and the content of stigmasterol is not more than that of campesterol.
Sesame oil
Shake 10 mL for about 1 minute with a mixture of 0.5 mL of a 0.35% v/v solution of furfuraldehyde in acetic anhydride and 4.5 mL of acetic anhydride in a cylinder closed with a ground-glass stopper, filter through paper impregnated with acetic anhydride and add 0.2 mL of sulfuric acid to the filtrate. No bluish green colour develops.
STORAGE
Olive Oil Ear Drops should be kept in a well-filled container and protected from light.
