Olive Oil
[8001-25-0].
(ol' iv oyl).
[8001-25-0].DEFINITION
Olive Oil is the refined fixed oil obtained from the ripe fruit of Olea europaea Linné (Fam. Oleaceae). It may contain suitable antioxidants.
IDENTIFICATION
• It meets the requirements for Fats and Fixed Oils, Fatty Acid Composition 
401
.
401. IMPURITIES
Inorganic Impurities
• Heavy Metals, Method II 231:
NMT 10 ppm
231:
NMT 10 ppm
• Alkaline Impurities
Sample:
10 mL of Olive Oil
Analysis:
Mix 10 mL of freshly opened acetone and 0.3 mL of water, and add 0.05 mL of bromophenol blue TS. Add the Sample, shake, and allow to stand. Titrate with 0.01 N hydrochloric acid VS to change the color of the upper layer to yellow.
Acceptance criteria:
NMT 0.1 mL of 0.01 N hydrochloric acid is required.
SPECIFIC TESTS
• Fats and Fixed Oils, Fatty Acid Composition 401:
Olive Oil exhibits the following composition profile of fatty acids.
401:
Olive Oil exhibits the following composition profile of fatty acids.
| Carbon-Chain Length | Number of Double Bonds | Percentage (%) |
|---|---|---|
| <16 | 0 |  0.1 |
| 16 | 0 | 7.5–20.0 |
| 16 | 1 | 3.5 |
| 18 | 0 | 0.5–5.0 |
| 18 | 1 | 56.0–85.0 |
| 18 | 2 | 3.5–20.0 |
| 18 | 3 | 1.2 |
| 20 | 0 | 0.7 |
| 20 | 1 | 0.4 |
| 22 | 0 | 0.2 |
| 24 | 0 | 0.2 |
• Absence of Sesame Oil
Sample:
10 mL of Olive Oil
Analysis:
Mix the Sample with a mixture of 0.5 mL of a 0.35% (v/v) solution of furfural in acetic anhydride and 4.5 mL of acetic anhydride, and shake the mixture for about 1 min. Pass through a filter paper previously wetted with acetic anhydride. Add 0.2 mL of sulfuric acid to the filtrate.
Acceptance criteria:
No bluish-green color develops.
• Fats and Fixed Oils, Acid Value 401:
NMT 0.3. [Note—Petroleum ether with 100–120
boiling range can be used to replace ether in the test. ]
401:
NMT 0.3. [Note—Petroleum ether with 100–120 boiling range can be used to replace ether in the test. ]
• Fats and Fixed Oils, Peroxide Value 401:
NMT 10.0.
401:
NMT 10.0.
• Fats and Fixed Oils, Unsaponifiable Matter 401:
NMT 1.5%. [Note—Petroleum ether with 40–60 boiling range can be used to replace ether in the test. ]
401:
NMT 1.5%. [Note—Petroleum ether with 40–60 boiling range can be used to replace ether in the test. ]
• Specific Absorbance
Sample solution:
Dissolve 1.0 g of Olive Oil in cyclohexane, and dilute with cyclohexane to 100 mL.
Spectrometric conditions
Mode:
UV-Vis
Wavelength:
270 nm
Analysis:
Determine the UV-Vis absorbance using the Spectrometric conditions described above.
Acceptance criteria:
The absorbance is NMT 1.20.
• Water Determination, Method Ic 921:
NMT 0.1%
921:
NMT 0.1%
• Fats and Fixed Oils, Sterol Composition 401:
Olive Oil exhibits the following composition profiles of sterols.
The content of stigmasterol is not greater than that of campesterol.
401:
Olive Oil exhibits the following composition profiles of sterols.
| Component | Percentage (%) |
|---|---|
| Cholesterol | 0.5 |
| Campesterol | 4.0 |
| D7-Stigmastenol | 0.5 |
Sum of the contents of D5,23-stigmastadienol, clerosterol,  -sitosterol, sitostanol, D5-avenasterol, and D5,24-stigmastadienol |
 93.0 |
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant, well-filled containers, and prevent exposure to excessive heat.
• Labeling:
Label it to indicate the name and quantity of any suitable antioxidants.
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 1879
Pharmacopeial Forum: Volume No. 35(1) Page 126