Packaging and storage— Preserve in tight containers,and prevent exposure to excessive heat.

Specific gravity á841ñ: between 0.910and 0.915.

Cottonseed oil— Mix 5mLin a test tube with 5mLof a mixture of equal volumes of amyl alcohol and a 1in 100solution of sulfur in carbon disulfide,warm the mixture carefully to expel the carbon disulfide,and immerse the test tube to one-third of its length in a boiling,saturated solution of sodium chloride for 2hours:the mixture develops no reddish color.

Peanut oil— Saponify 10g by heating for 1hour under a reflux condenser with 80mLof alcoholic potassium hydroxide TS.Add phenolphthalein TS,neutralize with 1Nacetic acid,and wash the solution into 120mLof boiling lead acetate TScontained in a conical flask.Boil the mixture for 1minute,and cool by immersing the flask in cold water,rotating the contents occasionally to cause the precipitate to adhere to the walls of the flask.Decant the liquid,wash the precipitate with cold water to remove the excess lead acetate,and then wash with 90percent (by volume)alcohol.Add 100mLof ether,stopper the flask,and allow to stand until the precipitate is disintegrated.Connect the flask to a reflux condenser,boil for 5minutes,cool to about 15,and allow to stand overnight.Filter,and thoroughly wash the precipitate with ether.With the use of a jet of ether,transfer the precipitate to a 500-mLseparator,alternating the jet of ether with 3Nhydrochloric acid at the end if any of the precipitate adheres to the filter paper.Add sufficient 3Nhydrochloric acid to make the total acid layer measure about 100mL,and add sufficient ether to make the ether layer measure about 100mL.Shake the mixture vigorously for several minutes,allow the layers to separate,draw off the acid layer,and wash the ether once by shaking with 50mLof 3Nhydrochloric acid and finally with several portions of water until the last washing is not acid to methyl orange TS.Transfer the ether solution to a dry flask,evaporate the ether,add a small amount of dehydrated alcohol,and evaporate on a steam bath to dryness.Dissolve the residue of dry fatty acids by warming with 60mLof 90percent (by volume)alcohol,slowly cool the solution to 15while shaking frequently,and allow the solution to stand at 15for 30minutes:no crystals separate from the solution.

Sesame oil— Mix 10mLwith 10mLof hydrochloric acid,add 0.1mLof a 1in 50solution of furfural in alcohol,and shake the mixture vigorously for 15seconds:no pink to crimson color appears in the acid layer when the emulsion breaks.If any color appears in the acid layer,add 10mLof water,and again shake the mixture vigorously:in the absence of sesame oil any pink color is evanescent.

Teaseed oil— In a dry,18-×150-mm test tube place 0.8mLof acetic anhydride,1.5mLof chloroform,and 0.2mLof sulfuric acid,mix,and cool in a water bath to 25.Add about 200mg of Olive Oil (about 7drops),mix,and cool to 25.If the solution is cloudy,add acetic anhydride,dropwise,shaking after each addition,until the solution suddenly clears.Allow the mixture to remain in the water bath for 5minutes:it shows a green color by both reflected and transmitted light.Add 10mLof absolute ether,and mix by inverting the tube:the initial green color fades to a brownish gray.(Before the dilution with ether,the presence of teaseed oilwill cause a brown color to appear by transmitted light,and after the dilution,a transient red color.)

Solidification range of fatty acids á401ñ— The dry,mixed fatty acids of it solidify between 17and 26.

Free fatty acids á401ñ— The free fatty acids in 10g require for neutralization not more than 5.0mLof 0.10Nsodium hydroxide.

Iodine value á401ñ: between 79and 88.

Saponification value á401ñ: between 190and 195.

Heavy metals,Method IIá231ñ: 0.001%.

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 3043

Phone Number:1-301-816-8262