Corn Oil
[8001-30-7].
(korn oyl).
[8001-30-7].DEFINITION
Corn Oil is the refined fixed oil obtained from the embryo of Zea mays Linné (Fam. Gramineae).
IDENTIFICATION
• A.
It meets the requirements of the test for Fats and Fixed Oils 
401
, Fatty Acid Composition.
401, Fatty Acid Composition.
IMPURITIES
• Alkaline Impurities
Sample:
10 mL of Corn Oil
Analysis:
Mix 10 mL of acetone and 0.3 mL of water, and add 0.05 mL of bromophenol blue TS. Neutralize the solution to a green color if necessary with 0.01 N hydrochloric acid or 0.01 N sodium hydroxide. 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.
• Heavy Metals, Method II 231:
NMT 10 ppm
231:
NMT 10 ppm
SPECIFIC TESTS
• Fats and Fixed Oils, Acid Value 401:
NMT 0.2
401:
NMT 0.2
• Fats and Fixed Oils, Fatty Acid Composition 401:
Corn Oil exhibits the composition profile of fatty acids in Table 1.
401:
Corn Oil exhibits the composition profile of fatty acids in Table 1.
Table 1
| Carbon-Chain Length | Number of Double Bonds |
Percentage (%) |
|---|---|---|
| <14 | 0 |  0.1 |
| 14 | 0 | 0.1 |
| 16 | 0 | 8.6–16.5 |
| 16 | 1 | 0.5 |
| 18 | 0 | 1.0–3.3 |
| 18 | 1 | 20.0–42.2 |
| 18 | 2 | 39.4–62.0 |
| 18 | 3 | 0.5–1.5 |
| 20 | 0 | 0.8 |
| 20 | 1 | 0.5 |
| 22 | 0 | 0.3 |
| 22 | 1 | 0.1 |
| 24 | 0 | 0.4 |
• Fats and Fixed Oils, Peroxide Value 401:
NMT 10.0
401:
NMT 10.0
• Fats and Fixed Oils, Sterol Composition 401:
The sterol fraction of the Corn Oil contains NMT 0.3% of brassicasterol.
401:
The sterol fraction of the Corn Oil contains NMT 0.3% of brassicasterol.
• Fats and Fixed Oils, Unsaponifiable Matter 401:
NMT 1.5%
401:
NMT 1.5%
• Water Determination, Method I 921:
NMT 0.1%. Use a mixture of equal volumes of decanol and anhydrous methanol as the solvent.
921:
NMT 0.1%. Use a mixture of equal volumes of decanol and anhydrous methanol as the solvent.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers, and avoid exposure to excessive heat.
• Labeling:
Where Corn Oil is intended for use in the manufacture of injectable dosage forms, it is so labeled.
• Other Requirements:
For Corn Oil intended for use in injectable dosage forms, specified in Labeling, the requirements for Acid Value, Peroxide Value, Unsaponifiable Matter, and Water in Other Vehicles under Injections 1, Ingredients must be met.
1, Ingredients must be met.
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 1764
Pharmacopeial Forum: Volume No. 34(5) Page 1220