Corn Oil
If you find any inaccurate information, please let us know by providing your feedback here
Tóm tắt nội dung
- DEFINITION
- IDENTIFICATION
- IMPURITIES
- SPECIFIC TESTS
- FATS AND FIXED OILS (401), Procedures, Acid Value
- FATS AND FIXED OILS (401), Procedures, Fatty Acid Composition
- FATS AND FIXED OILS (401), Procedures, Peroxide Value
- FATS AND FIXED OILS (401), Procedures, Sterol Composition
- FATS AND FIXED OILS (401), Procedures, Unsaponifiable Matter
- WATER DETERMINATION (921), Method I
- ADDITIONAL REQUIREMENTS
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
CAS RN®: 8001-30-7.
1 DEFINITION
Corn Oil is the refined fixed oil obtained from the embryo of Zea mays L. (Fam. Gramineae).
2 IDENTIFICATION
A. IDENTITY BY FATTY ACID COMPOSITION
Analysis: Proceed as directed in the test for Fats and Fixed Oils (401), Procedures, Fatty Acid Composition.
Acceptance criteria: Meets the composition profile of fatty acids in Table 1
B. IDENTITY BY TRIGLYCERIDE PROFILE
Analysis: Proceed as directed in Identification of Fixed Oils by Thin-Layer Chromatography (202), Identification, Method / or Method II.
Acceptance criteria: Meets the requirements in the chapter
3 IMPURITIES
3.1 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.
4 SPECIFIC TESTS
4.1 FATS AND FIXED OILS (401), Procedures, Acid Value
NMT 0.2
4.2 FATS AND FIXED OILS (401), Procedures, Fatty Acid Composition
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 |
4.3 FATS AND FIXED OILS (401), Procedures, Peroxide Value
NMT 10.0
4.4 FATS AND FIXED OILS (401), Procedures, Sterol Composition
The sterol fraction of the Corn Oil contains NMT 0.3% of brassicasterol.
4.5 FATS AND FIXED OILS (401), Procedures, Unsaponifiable Matter
NMT 1.5%
4.6 WATER DETERMINATION (921), Method I
NMT 0.1%. Use a mixture of equal volumes of decanol and anhydrous methanol as the solvent.
5 ADDITIONAL REQUIREMENTS
5.1 PACKAGING AND STORAGE
Preserve in tight, light-resistant containers, and avoid exposure to excessive heat.
5.2 LABELING
Where Corn Oil is intended for use in the manufacture of injectable dosage forms, it is so labeled.
5.3 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 under Injections and Implanted Drug Products (1), Product Quality Tests Common to Parenteral Dosage Forms, Specific Tests, Vehicles and added substances, Nonaqueous vehicles must be met.
