Hydrogenated Soybean Oil
[8016-70-4].
»Hydrogenated Soybean Oil is the product obtained by refining,bleaching,hydrogenation,and deodorization of oil obtained from seeds of the soya plant Glycine max Merr.(Fabaceae).The product consists mainly of triglycerides of palmitic and stearic acids.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at room temperature,and avoid excessive heat and freezing.Protect from moisture.
Identification—
A:
It meets the requirements of the test for Fatty acid composition.
B:
It meets the requirements of the test for Melting range.
Acid value á401ñ—
Dissolve about 10g of Hydrogenated Soybean Oil,accurately weighed,in 50mLof a hot mixture of neutralized alcohol and toluene (1:1),add 0.5mLof phenolphthalein TS,and immediately titrate,while still hot,with 0.1Npotassium hydroxide VSto produce a permanent,faint pink color:the acid value so obtained is not more than 0.5.
Peroxide value á401ñ:
not more than 5.0.
Unsaponifiable matter á401ñ:
not more than 1.0%,determined on 5.0g.
Fatty acid composition á401ñ—
Hydrogenated Soybean Oil exhibits the following composition profile of fatty acids,as determined in the section Fatty Acid Composition.
| Carbon-chain length |
No.of double bonds |
Percentage (%) |
| <14 | 0 | £0.1 |
| 14 | 0 | £0.5 |
| 16 | 0 | 9–16 |
| 18 | 0 | 79–89 |
| 20 | 0 | £1.0 |
| 22 | 0 | £1.0 |
| 18 | 1 | £4.0 |
| 18 | 2 | £1.0 |
| 18 | 3 | £0.2 |
Alkaline impurities—
Dissolve by gently heating 2.0g of Hydrogenated Soybean Oil in a mixture of 1.5mLof alcohol and 3.0mLof toluene.Add 0.05mLof bromophenol blue TS,and titrate with 0.01Nhydrochloric acid VSto a yellow endpoint:not more than 0.4mLof 0.01Nhydrochloric acid is required.
Water,Method Iá921ñ:
not more than 0.3%.
Limit of nickel—
Test solution—
Weigh 5.0g of Hydrogenated Soybean Oil into a previously tared platinum or silica crucible.Cautiously heat,and introduce into the substance a wick formed from twisted ashless filter paper.Ignite the wick.When the substance ignites,stop heating.After combustion,ignite in a muffle furnace at about 600
.Continue the incineration until white ash is obtained.After cooling,transfer the residue,with the aid of two 2-mLportions of diluted hydrochloric acid,to a 25-mLvolumetric flask,add 0.3mLof nitric acid,and dilute with water to volume.
.Continue the incineration until white ash is obtained.After cooling,transfer the residue,with the aid of two 2-mLportions of diluted hydrochloric acid,to a 25-mLvolumetric flask,add 0.3mLof nitric acid,and dilute with water to volume.
Nickel standard solution—
Immediately before use,dilute 10mLof nickel standard solution TSwith water to 500mL.This solution contains the equivalent of 0.2µg of nickel per g.
Standard solutions—
Into three identical 10-mLvolumetric flasks,introduce respectively 1.0mL,2.0mL,and 4.0mLof Nickel standard solution.To each flask,add a 2.0-mLportion of the Test solution,and dilute with water to volume.
Procedure—
Concomitantly determine the absorbances of the Standard solutionsand the Test solutionat least three times each,at the wavelength of maximum absorbance at 232.0nm,with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering á851ñ)equipped with a graphite furnace and a nickel hollow-cathode lamp.Record the average of the steady readings for each of the Standard solutionsand the Test solution.Plot the absorbances of the Standard solutionsand the Test solutionversus the added quantity of nickel,and draw the straight line best fitting the three plotted points.Extrapolate the line until it meets the concentration axis.The distance between this point and the intersection of the axes represents the concentration of nickel in the Test solution.Not more than 1µg per g is found.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3086
Pharmacopeial Forum:Volume No.30(3)Page 995
Phone Number:1-301-816-8251