Cottonseed Oil
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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: 8001-29-4.
1 DEFINITION
Cottonseed Oil is the rened xed oil obtained from the seed of cultivated plants of various varieties of Gossypium hirsutum L. or of other species of Gossypium (Fam. Malvaceae). It may contain suitable antioxidants.
2 IDENTIFICATION
A. Identity by Fatty Acid Composition: Cottonseed Oil exhibits the composition prole of fatty acids, as determined in Fats and Fixed Oils 〈401〉, Procedures, Fatty Acid Composition. See Table 1.
Table 1
| Carbon-Chain Length | Number of Double Bonds | Percentage (%) |
| <14 | 0 or 1 | ≤0.2 |
| 14 | 0 | 0.3-1.0 |
| 16 | 0 | 18.0-26.4 |
| 16 | 1 | ≤1 ,2 |
| 18 | 0 | 2.1-3.3 |
| 18 | 1 | 14.0-21.7 |
| 18 | 2 | 46.7-58.3 |
| 18 | 3 | ≤1 |
| 20 | 0 | ≤1 |
| 20 | 1 | ≤0.5 |
| 22 | 0 | ≤0.6 |
| 22 | 1 | ≤0.5 |
| 24 | 0 | ≤0.5 |
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
ALKALINE IMPURITIES
Sample: 10 mL of Cottonseed Oil
Analysis: Mix 10 mL of acetone and 0.3 mL. of water, and add 0.05 mL of bromophenol blue TS. If necessary, neutralize the solution to a green color 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
FATS AND FIXED OILS (401), Procedures, Acid Value: NMT 0.2
FATS AND FIXED OILS (401), Procedures, Peroxide Value: NMT 10.0
FATS AND FIXED OILS (401), Procedures. Unsaponifiable Matter: NMT 1.5%
WATER DETERMINATION (921), Method I. Method Ic: NMT 0.1%
5 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, light-resistant containers, and avoid exposure to excessive heat.
LABELING: Label it to indicate the name and quantity of any added antioxidants. Where Cottonseed Oil is intended for use in the manufacture of injectable dosage forms, it is so labeled.
OTHER REQUIREMENTS: For Cottonseed Oil intended for use in injectable dosage forms, which is specified in the Labeling section, the requirements 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.
