Hydrogenated Cottonseed Oil
»Hydrogenated Cottonseed Oil is the product obtained by refining and hydrogenating oil obtained from seeds of cultivated plants of various varieties ofGossypium hirsutum Linnéor of other species ofGossypium (Fam.Malvaceae).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 complies with the test forFatty acid composition.
B:
It complies with the test forMelting range.
Acid value á401ñ—
Dissolve about 10g of Hydrogenated Cottonseed Oil,accurately weighed,in 50mLof a hot mixture of neutralized alcohol and toluene (1:1),add 0.5mLof phenolphthalein TS,and titrate 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—
Hydrogenated Cottonseed Oil exhibits the following composition profile of fatty acids,as determined in the sectionFatty Acid Composition underFats and Fixed Oils á401ñ:
| Carbon-chain length |
No.of double bonds |
Percentage (%) |
| <14 | 0 | £0.2 |
| 14 | 0 | £1.0 |
| 16 | 0 | 19–26 |
| 18 | 0 | 68–80 |
| 20 | 0 | £1.0 |
| 22 | 0 | £1.0 |
| 24 | 0 | £0.5 |
| 18 | 1 | £4.0 |
| 18 | 2 | £1.0 |
Alkaline impurities—
Dissolve by gentle heating 2.0g of Hydrogenated Cottonseed Oil in a mixture of 1.5mLof alcohol and 3.0mLof toluene.Add 0.05mLof bromophenol blue TS,and titrate with 0.01Nhydrochloric acid to a yellow endpoint:not more than 0.4mLof 0.01Nhydrochloric acid is required.
Limit of nickel—
Test solution—
Weigh 5.0g of Hydrogenated Cottonseed 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 1.0,2.0,and 4.0mLofNickel standard solution.To each flask,add a 2.0-mLportion of theTest solution,and dilute with water to volume.
Procedure—
Concomitantly determine the absorbances of theStandard solutions and theTest solution at least three times each,at the wavelength of maximum absorbance at 232.0nm,with a suitable atomic absorption spectrophotometer (seeSpectrophotometry 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 theStandard solutions and theTest solution.Plot the absorbances of theStandard solutions and theTest solution versus the added quantity of nickel.Extrapolate the line joining the points on the graph until it meets the concentration axis.The distance between this point and the intersection of the axes represents the concentration of nickel in theTest 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 2991
Pharmacopeial Forum:Volume No.30(3)Page 974
Phone Number:1-301-816-8251