BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
Almond Oil Ear Drops are Virgin Almond 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 almond oil.
TESTS
Acid value
Not more than 2.0, Appendix X B. Use 5 g dissolved in 50 mL of the prescribed mixture of solvents.
Peroxide value
Not more than 10, Appendix X F.
Relative density
0.911 to 0.920, Appendix V G.
Unsaponifiable matter
Not more than 0.7% w/w, Appendix X H, Method II. Use 5 g.
Apricot-kernel oil and peach-kernel oil
Shake 2 mL for 5 minutes with a mixture of 1 mL of fuming nitric acid and 1 mL of water and allow to separate. No pink or brown colour develops in either layer.
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 C16Not more than 0.1%.
Palmitic acid 4.0 to 9.0%.
Palmitoleic acid (equivalent chain length on polyethylene glycol adipate, 16.3) Not more than 0.6%.
Margaric acid Not more than 0.2%.
Stearic acid Not more than 3.0%.
Oleic acid (equivalent chain length on polyethylene glycol adipate, 18.3) 62.0 to 86.0%.
Linoleic acid (equivalent chain length on polyethylene glycol adipate, 18.9) 20.0 to 30.0%.
Linolenic acid (equivalent chain length on polyethylene glycol adipate, 19.7) Not more than 0.4%.
Arachidic acid Not more than 0.1%.
Gadoleic acid (equivalent chain length on polyethylene glycol adipate, 20.3) Not more than 0.1%.
Behenic acid Not more than 0.1%.
Erucic acid (equivalent chain length on polyethylene glycol adipate, 22.3) Not more than 0.1%.
Sterols
Carry out the test for sterols in fatty oils, Appendix X N. The sterol fraction of the oil has the following composition.
Cholesterol Not more than 0.7%.
Campesterol Not more than 4.0%.
Stigmasterol Not more than 3.0%.
β-Sitosterol 73.0% to 87.0%.
Δ5 -Avenasterol At least 10.0%.
Δ7 -Avenasterol Not more than 3.0%.
Δ7 -Stigmastenol Not more than 3.0%.
Fucosterol Not more than 2.0%.
Brassicasterol Not more than 0.3%.
Sesame oil
Shake 10 mL with 5 mL of a mixture of 0.5 volume of a 0.35% v/v solution of furfuraldehyde in acetic anhydride and 4.5 volumes of acetic anhydride for 1 minute, filter through a filter paper impregnated with acetic anhydride and add 0.2 mL of sulfuric acid. No bluish green colour develops.
STORAGE
Almond Oil Ear Drops should be kept in a well-filled container and protected from light.
