(kot' un seed oyl).
Cottonseed Oil is the refined fixed oil obtained from the seed of cultivated plants of various varieties of Gossypium hirsutum Linné or of other species of Gossypium (Fam. Malvaceae). It may contain suitable antioxidants.
• A. Cottonseed Oil exhibits the composition profile of fatty acids, as determined in the general test chapter Fats and Fixed Oils 401, Fatty Acid Composition. See Table 1.
• Alkaline Impurities
Sample: 10 mL of Cottonseed Oil
Anaylsis: 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.
• Heavy Metals, Method II 231: NMT 10 ppm
• Fats and Fixed Oils, Acid Value 401: NMT 0.2
• Fats and Fixed Oils, Peroxide Value 401: NMT 10.0
• Fats and Fixed Oils, Unsaponifiable Matter 401: NMT 1.5%
• Water Determination, Method Ic 921: NMT 0.1%
• 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 in the subsection Other Vehicles in the section Ingredients under Injections 1 must be met.