Coconut oil.
Coconut oil [8001-31-8].

Packaging and storage— Preserve in tight, light-resistant, well-filled containers. No storage requirement specified.

Identification— It meets the requirements of the test for Fatty acid composition.

Melting range 741: between 23 and 26.

Acid value 401: not more than 0.5, determined on 20.0 g.

Peroxide value 401: not more than 5.0.

Unsaponifiable matter 401: not more than 1.0%.

Fatty acid composition— Coconut Oil exhibits the following composition profile of fatty acids, as determined in the section Fatty Acid Composition under Fats and Fixed Oils 401:

Water, Method I 921: not more than 0.1%, 50 mL of chloroform being used as the solvent instead of 35 to 40 mL of methanol.

Arsenic, Method II 211: not more than 0.5 µg per g.

Alkaline impurities— Mix 10 mL of freshly distilled acetone and 0.3 mL of water, and add 0.05 mL of bromophenol blue TS. Neutralize the solution to green color if necessary with 0.01 N hydrochloric acid or 0.01 N sodium hydroxide. Add 10 mL of Coconut Oil, shake, and allow to stand. Titrate with 0.01 N hydrochloric acid VS to change the color of the upper layer to yellow: not more than 0.1 mL of 0.01 N hydrochloric acid VS is required.

Expert Committee : (EM205) Excipient Monographs 2

USP31–NF26 Page 1114

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