二ステアリン酸マグネシウム

外観

白色〜ほとんど白色, 粉末

定義

本品は、ステアリン酸(*)のマグネシウム塩であり、次の化学式で表される。
参照表示名称：ステアリン酸

溶解性

水又はエタノール(99.5)にほとんど溶けない。

用途

塩化ビニル安定剤、錠剤の潤滑剤

用途

滑剤、安定剤、分散剤。

用途

医薬品・化粧品原料(滑沢剤)及び研究用。

用途

潤滑剤、撥水剤、安定剤、増粘剤、ツヤ消剤、離型剤、加硫促進剤、グリース基材、保険機能食品、化粧品原料(清浄用化粧品、頭髪用化粧品、基礎化粧品、メークアップ化粧品、芳香化粧品、日焼け?日焼け止め化粧品、爪化粧品、アイライナー化粧品、口唇化粧品、口腔化粧品、入浴用化粧品)

化粧品の成分用途

非水系増粘剤、抗ケーキング剤、増量剤、着色剤

効能

錠・カプセル潤滑剤

説明

Magnesium stearate, also called octa decanoic acid, magnesium salt, is a white substance, powder which becomes solid at room temperature. It has the chemical formula Mg(C₁₈H₃₅O₂)₂. It is a salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg2+). Magnesium stearate melts at about 120 °C, is not soluble in water, and is generally considered safe for human consumption at levels below 2500 mg/kg per day.In 1979, the FDA's Subcommittee on GRAS (generally recognized as safe) Substances (SCOGS) reported, "There is no evidence in the available information on ... magnesium stearate ... that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future.".

化学的特性

Magnesium stearate is a very fine, light white, precipitated or milled, impalpable powder of low bulk density, having a faint odor of stearic acid and a characteristic taste. The powder is greasy to the touch and readily adheres to the skin. nonflammable used in baby dusting powder(s) and as tablet lubricant.

使用

Magnesium Stearate is the magnesium salt of stearic acid which functions as a lubricant, binder, emulsifier, and anticaking agent. it is a white powder that is insoluble in water. it is used as a lubricant or die release in tableting pressed candies and is also used in sugar- less gum and mints.

定義

Mg(C18H35O2)2 or with one H2O. Technical grade contains small amounts of the oleate and 7% magnesium oxide, MgO.

製造方法

Magnesium stearate is created by the reaction of sodium stearate with magnesium sulfate.

調製方法

Magnesium stearate is prepared either by the interaction of aqueous solutions of magnesium chloride with sodium stearate or by the interaction of magnesium oxide, hydroxide, or carbonate with stearic acid at elevated temperatures.

一般的な説明

Magnesium stearate (Mg-St) is the magnesium salt of stearic acid. Its anhydrate, dihydrate and trihydrate forms have been prepared. The tabletting of the blends of magnesium stearate and lactose granules has been described. The influence of mixing time on hardness, disintegration time and ejection force on the compressed tablets was examined. Mg-St is widely used lubricant in pharmaceutical industry. It also plays a role in delaying the process of dissolution. Its detection in tablets by laser-induced breakdown spectroscopy has been proposed.

応用例（製薬）

Magnesium stearate is widely used in cosmetics, foods, and pharmaceutical formulations. It is primarily used as a lubricant in capsule and tablet manufacture at concentrations between 0.25% and 5.0% w/w. It is also used in barrier creams.

安全性プロファイル

Slightly toxic by ingestion. Spontaneously combustible. When heated to decomposition it emits acrid smoke and toxic fumes.

安全性

Magnesium stearate is widely used as a pharmaceutical excipient and is generally regarded as being nontoxic following oral administration. However, oral consumption of large quantities may produce a laxative effect or mucosal irritation.
No toxicity information is available relating to normal routes of occupational exposure. Limits for heavy metals in magnesium stearate have been evaluated in terms of magnesium stearate worstcase daily intake and heavy metal composition.
Toxicity assessments of magnesium stearate in rats have indicated that it is not irritating to the skin, and is nontoxic when administered orally or inhaled.
Magnesium stearate has not been shown to be carcinogenic when implanted into the bladder of mice.
LD₅₀ (rat, inhalation): >2 mg/L
LD₅₀ (rat, oral): >10 g/kg

貯蔵

Magnesium stearate is stable and should be stored in a well-closed container in a cool, dry place.

不和合性

Incompatible with strong acids, alkalis, and iron salts. Avoid mixing with strong oxidizing materials. Magnesium stearate cannot be used in products containing aspirin, some vitamins, and most alkaloidal salts.

規制状況(Regulatory Status)

GRAS listed. Accepted as a food additive in the USA and UK. Included in the FDA Inactive Ingredients Database (oral capsules, powders, and tablets; buccal and vaginal tablets; topical preparapreparations; intravitreal implants and injections). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. Listed on the US TSCA inventory.