Safflower Oil
(saf' low er oyl).
DEFINITION
Safflower Oil is the refined fixed oil yielded by the seed of Carthamus tinctorius L. (Fam. Compositae).
IMPURITIES
• Heavy Metals, Method II 
231
:
NMT 10 ppm
231:
NMT 10 ppm
SPECIFIC TESTS
• Fats and Fixed Oils, Acid Value (Free Fatty Acids) 401:
The free fatty acids in 10 g require for neutralization NMT 2.5 mL of 0.020 N sodium hydroxide.
401:
The free fatty acids in 10 g require for neutralization NMT 2.5 mL of 0.020 N sodium hydroxide.
• Fatty Acid Composition
1 N methanolic potassium hydroxide solution:
Dissolve 34 g of potassium hydroxide in sufficient methanol to produce 500 mL. Allow to settle for 24 h, and decant the clear solution.
Sample solution:
Place 1 g of Safflower Oil in a small conical flask fitted with a reflux attachment. Add 10 mL of methanol and 0.5 mL of 1 N methanolic potassium hydroxide solution. Reflux the mixture for 10 min, cool, transfer to a separator with the aid of 15 mL of n-heptane, shake with 10 mL of saturated sodium chloride solution, and allow to separate. Transfer the lower layer to another separator, and shake it with 10 mL of n-heptane. Wash the combined organic layers with 10 mL of water, dry over anhydrous sodium sulfate, and filter. Use a suitable portion of the filtrate.
Chromatographic system
Mode:
GC
Detector:
Flame ionization
Column:
4-mm × 1.5-m; packed with 10% liquid phase G4 on support S1A
Column temperature:
175
Carrier gas:
Nitrogen
Analysis
Sample:
Sample solution
Inject a suitable volume into the chromatograph, and measure the 4 main peak areas of the methyl esters of the fatty acids. The order of elution is palmitate, stearate, oleate, and linoleate.
Calculate the percentage of palmitate, stearate, oleate, and linoleate in the portion of Safflower Oil taken:
Result = (A/B) × 100
| A | = | = peak area of palmitate, stearate, oleate, or linoleate |
| B | = | = total area of the 4 main peaks |
Acceptance criteria:
See Table 1.
Table 1
| Percentage (%) |
|
|---|---|
| Palmitate | 2–10 |
| Stearate | 1–10 |
| Oleate | 7–42 |
| Linoleate | 72–84 |
• Fats and Fixed Oils, Unsaponifiable Matter 401:
NMT 1.5%
401:
NMT 1.5%
• Limit of Peroxide
Solvent A:
Chloroform and glacial acetic acid (40:60)
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 Solvent A and starch TS.
Sample:
10 g of Safflower Oil
Analysis:
Transfer the Sample to a conical flask, add 30 mL of Solvent A, and swirl to dissolve. Add 0.5 mL of Potassium iodide solution; swirl the flask for 1 min, accurately timed; add 30 mL of water; and titrate with 0.01 N sodium thiosulfate VS, with vigorous agitation, to a light yellow color. Add 0.5 mL of 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/kg, in the portion of Safflower Oil taken:
Result = F × V × N/W
| F | = | = conversion factor from g to kg, 1000 g/kg |
| V | = | = volume of sodium thiosulfate required in the titration (mL) |
| N | = | = normality of the sodium thiosulfate VS |
| W | = | = weight of Safflower Oil taken (g) |
Acceptance criteria:
NMT 10.0
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 4600