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Castor oil, hydrogenated
روغن کرچک هیدروژنه
1Nonproprietary names
- BPHydrogenated Castor Oil
- Ph. Eur.Castor Oil, Hydrogenated
- USP–NFHydrogenated Castor Oil
2Synonyms and trade names
Castor wax; Castorwax; Cutina HR; glyceryl tri(12-hydroxystearate); Kolliwax HCO; opal wax; ricini oleum hydrogenatum; trihydroxystearin
3Chemical name and CAS Registry Number
Mainly glyceryl tri(12-hydroxystearate) · [8001-78-3]
4Empirical formula and molecular weight
C57H110O9 · 939.5
5Functional category
Lubricant, Semi-solid base, emollient
Typical concentrations: 0.1–2% lubricant · Dosage forms: Solid, Semi-solid
6Applications in pharmaceutical formulation
Used as a hydrophobic matrix former and coating material in sustained-release tablets and capsules, as a tablet lubricant, and as a stiffening agent in creams, ointments, sticks and suppository bases. It is also used in cosmetics.
7Description
A fine, white to yellowish-white, waxy powder, flakes or pellets with little or no odour.
8Typical properties
- Melting range
- ≈ 83–88 °C
- Hydroxyl value
- 145–165
- Iodine value
- ≤ 5
- Solubility
- practically insoluble in water and light petroleum; slightly soluble in methylene chloride; very slightly soluble in ethanol
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents.
11Method of manufacture
Prepared by catalytic hydrogenation of refined castor oil, usually with a nickel catalyst, which saturates the double bond of ricinoleic acid to give 12-hydroxystearic acid esters.
12Safety
Regarded as non-toxic and non-irritant in oral and topical products at the levels used.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and tablets; topical preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Castor oil; hydrogenated vegetable oil; polyoxyl 40 hydrogenated castor oil.
16Comments
The hydroxyl groups give it a higher melting point and greater polarity than other hydrogenated vegetable oils; it can be incorporated by melt granulation or hot-melt extrusion as well as by direct blending.