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Calcium stearate
کلسیم استئارات
1Nonproprietary names
- BPCalcium Stearate
- JPCalcium Stearate
- Ph. Eur.Calcium Stearate
- USP–NFCalcium Stearate
2Synonyms and trade names
Calcii stearas; calcium distearate; calcium octadecanoate; octadecanoic acid, calcium salt; stearic acid, calcium salt; E470a
3Chemical name and CAS Registry Number
Octadecanoic acid calcium salt · [1592-23-0]
UNII 776XM7047L · PubChem CID 15324
4Empirical formula and molecular weight
C36H70CaO4 · 607.0
5Functional category
Lubricant
Typical concentrations: up to 1% · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used mainly as a lubricant in tablet and capsule manufacture, usually at up to about 1% w/w. It is also used as an emulsifier and stabiliser, as a water-repellent and anticaking agent, and in foods and cosmetics.
7Description
A fine, white to yellowish-white, bulky powder with a slight, characteristic odour. It is unctuous to the touch and free from grittiness.
8Typical properties
- Composition
- mixture of calcium salts of fatty acids, mainly stearic and palmitic acid; Ph. Eur. requires stearic acid ≥ 40% and stearic plus palmitic acid ≥ 90% of the fatty-acid fraction
- Calcium content
- 6.4–7.4% (dried substance, Ph. Eur.)
- Melting behaviour
- softens and melts at about 150–160 °C (grade-dependent)
- Solubility
- practically insoluble in water, ethanol and ether; slightly soluble in hot ethanol and in hot vegetable and mineral oils
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents and strong acids. Like other metallic stearates it is hydrophobic and can slow wetting and dissolution if over-blended.
11Method of manufacture
Prepared by reacting a soluble calcium salt such as calcium chloride with sodium stearate in aqueous solution, or by reacting calcium oxide or hydroxide with stearic acid.
12Safety
Used in oral pharmaceuticals and foods and regarded as non-toxic and non-irritant at the levels employed.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection, gloves and a dust mask are recommended where dust is generated.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E470a). Included in the FDA Inactive Ingredient Database (oral capsules and tablets) and in non-parenteral medicines licensed in Europe.
15Related substances
Magnesium stearate; stearic acid; zinc stearate; sodium stearyl fumarate.
16Comments
Calcium stearate is used less often than magnesium stearate but is an alternative where magnesium stearate is unsuitable; as with all metallic stearate lubricants, the lowest effective level and short blending times are advisable.