Stearic Acid

Stearic Acid is known as emulsifying agent, solubilizing agent, tablet and capsule lubricant. This product is available in Arvin Kala’s diverse product portfolio.

Description

Stearic acid is a hard, white or faintly yellow-colored, somewhat glossy, crystalline solid or a white or yellowish white powder. It has a slight odor (with an odor threshold of 20 ppm) and taste suggesting tallow.

Applications in Pharmaceutical Formulation or Technology

Stearic acid is widely used in oral and topical pharmaceutical formulations. It is mainly used in oral formulations as a tablet and capsule lubricant; see Table I, although it may also be used as a binder or in combination with shellac as a tablet coating. It has also been suggested that stearic acid may be used in enteric tablet coatings and as a sustained-release drug carrier. In topical formulations, stearic acid is used as an emulsifying and solubilizing agent. When partially neutralized with alkalis or triethanolamine, stearic acid is used in the preparation of creams. The partially neutralized stearic acid forms a creamy base when mixed with 5–۱۵ times its own weight of aqueous liquid, the appearance and plasticity of the cream being determined by the proportion of alkali used. Stearic acid is used as the hardening agent in glycerin suppositories. Stearic acid is also widely used in cosmetics and food products.

Stability and Storage Conditions

Stearic acid is a stable material; an antioxidant may also be added to it. The bulk material should be stored in a well closed container in a cool, dry place.

Method of Manufacture

Stearic acid is manufactured by hydrolysis of fat by continuous exposure to a countercurrent stream of high-temperature water and fat in a high-pressure chamber. The resultant mixture is purified by vacuum steam distillation and the distillates are then separated using selective solvents. Stearic acid may also be manufactured by the hydrogenation of cottonseed and other vegetable oils; by the hydrogenation and subsequent saponification of olein followed by recrystallization from alcohol; and from edible fats and oils by boiling with sodium hydroxide, separating any glycerin, and decomposing the resulting soap with sulfuric or hydrochloric acid. The stearic acid is then subsequently separated from any oleic acid by cold expression. Stearic acid is derived from edible fat sources unless it is intended for external use, in which case nonedible fat sources may be used. The USP32–NF27 states that stearic acid labeled solely for external use is exempt from the requirement that it be prepared from edible sources. Stearic acid may contain a suitable antioxidant such as 0.005% w/w butylated hydroxytoluene.

Safety

Stearic acid is widely used in oral and topical pharmaceutical formulations; it is also used in cosmetics and food products. Stearic acid is generally regarded as a nontoxic and nonirritant material. However, consumption of excessive amounts may be harmful.

LD50 (mouse, IV): 23 mg/kg

LD50 (rat, IV): 21.5 mg/kg

Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Stearic acid dust may be irritant to the skin, eyes, and mucous membranes. Eye protection, gloves, and a dust respirator are recommended. Stearic acid is combustible.

Chemical-physical values

Test Item Unit Specification

Description

_

White or yellowish-white Powder

Freezing Poin
°C
Between 53-59
Acid Value
KOH/g
Between 194-212
RetentionTime of Major Peak
_

Complies

Stearic acid Composition
%
Between 40-60
Test Item Unit Specification

Stearic+ Palmitic acid composition

%

NLT 90

Residue On Ignition
%
Max 0.1
Heavy Metal
Ppm
Max 10
Nickel
Ppm
Max 1
Fat& Fixed Oil, Iodine Value
gI2/100g
Max 4

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