Safflower Oil
»Safflower Oil is the refined fixed oil yielded by the seed of Carthamus tinctoriusLinné(Fam.Compositae).
Packaging and storage— Preserve in tight,light-resistant containers.
Fatty acid composition— Place about 1g of Oil in a small conical flask fitted with a reflux attachment.Add 10mLof methanol and 0.5mLof 1Nmethanolic potassium hydroxide solution prepared by dissolving 34g of potassium hydroxide in sufficient methanol to produce 500mL,allow to settle for 24hours,and decant the clear solution.Reflux the mixture for 10minutes,cool,transfer to a separator with the aid of 15mLof n-heptane,shake with 10mLof saturated sodium chloride solution,and allow to separate.Transfer the lower layer to another separator,and shake it with 10mLof n-heptane.Wash the combined organic layers with 10mLof water,dry over anhydrous sodium sulfate,and filter.Introduce a suitable portion of the filtrate into a gas chromatograph equipped with a flame-ionization detector and a column,preferably glass,1.5m in length and 4mm in internal diameter packed with 10%liquid phase G4on support S1A,maintained at a temperature of 175.The carrier gas is nitrogen.Measure the 4main peak areas of the methyl esters of the fatty acids.The order of elution is palmitate,stearate,oleate,and linoleate,and their relative areas,expressed as percentages of the total area of the 4main peaks,are in the ranges 2to 10,1to 10,7to 42,and 72to 84,respectively.
Free fatty acids á401ñ— The free fatty acids in 10g require for neutralization not more than 2.5mLof 0.020Nsodium hydroxide.
Iodine value,Method IIá401ñ: between 135and 150.
Unsaponifiable matter á401ñ: not more than 1.5%.
Peroxide—
Mixed solvent— Mix 60mLof glacial acetic acid with 40mLof chloroform.
Potassium iodide solution— Prepare a saturated solution of potassium iodide in freshly boiled and cooled water,and store it protected from light.Discard it if it gives a color on addition of Mixed solventand starch TS.
Procedure— Transfer about 10g of Oil,accurately weighed,to a conical flask,add 30mLof Mixed solvent,swirl to dissolve,add 0.5mLof Potassium iodide solution,swirl the flask for 1minute,accurately timed,add 30mLof water,and titrate with 0.01Nsodium thiosulfate VS,with vigorous agitation,to a light yellow color.Add 0.5mLof starch TS,and continue the titration until the blue color has disappeared.Perform a blank test,and make any necessary correction.Calculate the peroxide content,in mEq per kg,by the formula:
1000VN/W,
in which Vis the volume,in mL,of sodium thiosulfate required,Nis its normality,and Wis the weight,in g,of Oil taken.The limit is 10.0.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 1746
Phone Number:1-301-816-8262