Chemical Properties
Pale-yellow, fixed drying oil.Soluble in alcohol, ether,
chloroform, and carbon disulfide. Combustible.
Uses
Pharmaceutic necessity.
General Description
Pale yellow oily liquid with a weak odor. Floats on water. Contains principally glycerides of oleic and linoleic acids.
Air & Water Reactions
Insoluble in water.
Reactivity Profile
SOYBEAN OIL react with acids to liberate heat. Heat is also generated by interaction with caustic solutions. Strong oxidizing acids may cause a vigorous reaction that is sufficiently exothermic to ignite the reaction products. Flammable hydrogen is generated by mixing with alkali metals and hydrides. React slowly with oxygen in the air to become rancid.
Health Hazard
None-is a food.
Application
Soybean Oil is a vegetable oil which come from the seeds of the soybean plant. It is commonly used as a cooking oil. Like with many oils it breaks down at high temperatures to producing volatile aldehydes.
Definition
Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic.
Production Methods
Obtained by solvent extraction using petroleum hydrocarbons, or
to a lesser extent by expression using continuous screw-press
operations, of the seeds of either Glycine max (Leguminosae) or
Glycine soja (Leguminosae). The oil is refined, deodorized, and
clarified by filtration at about 0℃. Any phospholipids or sterols
present are removed by refining with alkali.
Pharmaceutical Applications
In pharmaceutical preparations, soybean oil emulsions are primarily
used as a fat source in total parenteral nutrition (TPN)
regimens. Although other oils, such as peanut oil, have been
used for this purpose, soybean oil is now preferred because it is
associated with fewer adverse reactions. Emulsions containing
soybean oil have also been used as vehicles for the oral and
intravenous administration of drugs; drug substances that have
been incorporated into such emulsions include amphotericin,
diazepam, retinoids, vitamins, poorly water-soluble steroids, fluorocarbons, ibuprofen, and insulin. In
addition, soybean oil has been used in the formulation of many drug
delivery systems such as liposomes, microspheres, dry
emulsions, self-emulsifying systems, microemulsions,nanoemulsions and nanocapsules, solid-in-oil suspensions, and multiple emulsions.
Soybean oil may also be used in cosmetics and is consumed as an
edible oil. As soybean oil has emollient properties, it is used as a
bath additive in the treatment of dry skin conditions.
Safety
Soybean oil is widely used intramuscularly as a drug vehicle or as a
component of emulsions used in parenteral nutrition regimens; it is
also consumed as an edible oil. Generally, soybean oil is regarded as
an essentially nontoxic and nonirritant material. However, serious
adverse reactions to soybean oil emulsions administered parenterally
have been reported. These include cases of hypersensitivity, CNS reactions, and fat embolism. Interference with the
anticoagulant effect of warfarin has also been reported.
Anaphylactic reactions have also been reported following the
consumption of foods derived from, or containing, soybeans.
Recently there has been concern at the concentration of phytoestrogens
in some soy-derived products. Administration of soy protein to
humans has resulted in significantly decreased serum lipid
concentrations.
In 1999, the UK Medical Devices Agency announced the
voluntary withdrawal of a breast implant that contained soybean
oil. The decision was taken because not enough was known at that time about the long-term safety and the rate of breakdown of the
soybean oil in the filling and its possible effects on the body.
LD50 (mouse, IV): 22.1 g/kg
LD50 (rat, IV): 16.5 g/kg
storage
Soybean oil is a stable material if protected from atmospheric
oxygen.
The formation of undesirable flavors in soybean oil is
accelerated by the presence of 0.01 ppm copper and 0.1 ppm iron,
which act as catalysts for oxidation; this can be minimized by the
addition of chelating agents.
Prolonged storage of soybean oil emulsions, particularly at
elevated temperatures, can result in the formation of free fatty acids,
with a consequent reduction in the pH of the emulsion; degradation
is minimized at pH 6–7. However, soybean oil emulsions are stable
at room temperature if stored under nitrogen in a light-resistant
glass container. Plastic containers are permeable to oxygen and
should not be used for long-term storage since oxidative degradation
can occur.
The stability of soybean oil emulsions is considerably influenced
by other additives in a formulation.
Soybean oil should be stored in a well-filled, airtight, lightresistant
container at a temperature not exceeding 25℃.
Incompatibilities
Soybean oil emulsions have been reported to be incompatible at
25°C with a number of materials including calcium chloride,
calcium gluconate, magnesium chloride, phenytoin sodium, and
tetracycline hydrochloride. Lower concentrations of these
materials, or lower storage temperatures, may result in improved
compatibility. The source of the material may also affect compatibility;
for example, while one injection from a particular
manufacturer might be incompatible with a fat emulsion, an
injection with the same amount of active drug substance from
another manufacturer might be compatible.
Amphotericin B has been reported to be incompatible with
soybean oil containing fat emulsions under certain conditions.
Soybean oil emulsions are also incompatible with many other
drug substances, IV infusion solutions, and ions (above certain
concentrations).
When plastic syringes are used to store soybean oil emulsion,
silicone oil may be extracted into the emulsion; swelling of the
syringe pump also occurs, resulting in the necessity for increased
forces to maintain the motion of the plunger.
Regulatory Status
Included in the FDA Inactive Ingredients Database (IV injections,
oral capsules, and topical preparations). Included in nonparenteral
(chewable tablets; oral capsules; oral lozenges; topical bath
additives) and parenteral (emulsions for IV injection or infusion)
medicines licensed in the UK. Included in the Canadian List of
Acceptable Non-medicinal Ingredients.
