(pee' nut oyl).
Peanut Oil is the fully-refined (alkali-refined, bleached, and deodorized at 230260) oil obtained from the seed kernels of one or more of the cultivated varieties of Arachis hypogaea Linné (Fam. Leguminosae). It may contain suitable antioxidants.
• Heavy Metals, Method II 231: NMT 10 ppm
• Alkaline Impurities
Sample: 10 mL of Peanut 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.
• Fats and Fixed Oils, Fatty Acid Composition 401: Peanut Oil exhibits the following fatty acid composition profile.
Sample: 1 mL of a solution (1 in 10) of Oil in ether
Analysis: Shake the Sample with 1 mL of hydrochloric acid, and add 1 mL of a solution (1 in 1000) of phloroglucinol in ether.
Acceptance criteria: No red or pink color develops.
• Fats and Fixed Oils, Acid Value 401: NMT 0.2
• Fats and Fixed Oils, Peroxide Value 401: NMT 5.0
• Fats and Fixed Oils, Unsaponifiable Matter 401: NMT 1.5%
• Water Determination, Method Ic 921: NMT 0.1%.
• Other Requirements: For Peanut Oil intended for use in injectable dosage forms, which is specified in the Labeling, the requirements under Injections 1, Ingredients, Other Vehicles, must be met.
• Packaging and Storage: Preserve in tight, light-resistant containers, and prevent exposure to excessive heat.
• Labeling: Label it to indicate the name and quantity of any added antioxidant. Where Peanut Oil is intended for use in the manufacture of injectable dosage forms, it is so labeled.