PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Cottonseed oil
روغن پنبهدانه
1Nonproprietary names
- USP–NFCottonseed Oil
2Synonyms and trade names
cotton seed oil; gossypii oleum; Gossypium oil; refined cottonseed oil
3Chemical name and CAS Registry Number
Cottonseed oil (refined fixed oil; mixed triglycerides mainly of linoleic, palmitic and oleic acids) · [8001-29-4]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Oleaginous vehicle
Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)
6Applications in pharmaceutical formulation
Used as a solvent and vehicle for intramuscular injections, as the oil phase of oral and topical emulsions, as a fill vehicle in soft capsules and in topical preparations. It is also widely used as an edible oil. Like other fixed oils used as vehicles, it is often the main or only liquid in the formulation.
7Description
A pale yellow or bright golden-yellow, clear, oily liquid that is odourless or nearly so, with a bland, nutty taste. Below about 10 °C particles of solid fat may separate, and at around 0 to −5 °C the oil becomes solid or nearly so.
8Typical properties
- Fatty-acid composition
- roughly linoleic acid about 50%, palmitic acid about 25% and oleic acid about 18%, with small amounts of stearic and myristic acids
- Specific gravity
- about 0.915–0.921 at 25 °C
- Iodine value
- about 109–120
- Solubility
- miscible with chloroform, ether, hexane and carbon disulfide; slightly soluble in ethanol; practically insoluble in water
9Stability and storage conditions
Stable if stored in a well-filled, airtight, light-resistant container in a cool place; exposure to air and light leads to oxidation and rancidity. Solid fat may separate at low temperatures and redissolves on gentle warming.
10Incompatibilities
Incompatible with strong oxidising agents.
11Method of manufacture
Obtained by expression or solvent extraction of the seeds of cultivated cotton plants (Gossypium hirsutum and other Gossypium species). The crude oil is refined, which removes the toxic pigment gossypol, and is usually winterised to remove the higher-melting glycerides.
12Safety
Refined cottonseed oil is a food oil and is generally regarded as non-toxic and non-irritant. Crude oil and seed contain gossypol, which is toxic, but this is removed in refining. Hypersensitivity reactions to cottonseed have occasionally been reported.
13Handling precautions
Observe normal precautions for the quantity handled. Spilt oil is slippery.
14Regulatory status
GRAS listed. Included in the FDA Inactive Ingredient Database (intramuscular injections; oral capsules and tablets; topical preparations).
15Related substances
Hydrogenated cottonseed oil; corn oil; peanut oil; sesame oil; soybean oil.
16Comments
Hydrogenated cottonseed oil, a solid fat used as a tablet lubricant and in lipid matrices, is a different material with its own Ph. Eur. and USP–NF monographs. For injections, low-peroxide grades and protection from oxidation are needed.