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순도시험
(1) 납 : 이 품목 5.0g을 취하여 원자흡광광도법 또는 유도결합플라즈마발광광도법에 따라 시험할 때, 그 양은 5.0ppm 이하이어야 한다.
(2) 염화물 : 이 품목 5g을 취하여 환저플라스크에 넣고, 과산화물을 함유하고 있지 않은 디에틸에테르 50mL , 묽은질산 20mL 및 물 20mL를 가한 다음, 환류냉각기를 장착하고 완전히 녹을 때 까지 가열한다. 냉각한 다음, 플라스크의 내용물을 분액깔대기에 옮기고 흔들어 섞은 후, 방치하여 수층을 분취한다. 디에틸에테르층을 물 4mL로 2회 추출하여 추출액을 합하고, 디에틸에테르 15mL로 세정한 다음 물을 가하여 정확히 50mL로 한 액을 시험용액으로 한다. 시험용액 10mL를 취하여 염화물시험법에 따라 시험할 때, 그 양은 0.02N 염산 1.4mL에 대응하는 양 이하이어야 한다(0.10% 이하).
(3) 황산염 : 순도시험 (2)의 시험용액 10mL를 취하여 황산염시험법에 따라 시험할 때, 그 양은 0.02N 황산 10.2mL에 대응하는 양 이하이어야 한다(1.0% 이하).
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확인시험
(1) 이 품목 1g에 염산(1→6)을 가하여 가열하고 식힐 때, 상층에는 지방산층이 뜨고 하층의 수용액은 확인시험법 중 마그네슘염의 반응을 나타낸다.
(2) 이 품목 25g을 뜨거운 물 200mL와 혼합하고 묽은황산 60mL를 가하고 자주 저어 주면서 투명한 상층액이 분리될 때까지 가열한 다음 황산이온이 없을 때까지 뜨거운 물로 충분히 세척하고 작은 비이커에 옮겨 증기욕상에서 지방산이 투명하게 될 때까지 수분을 분리시키고 방치한 후 물층은 버리고 지방산층은 가열용융하여 여과한 후 105℃에서 20분간 건조시키고 응고점시험법에 따라 시험할 때, 54℃이상이어야 한다.
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정량법
이 품목 약 1g을 정밀히 달아 0.1N 염산 50mL를 가하고 때때로 물을 보충하면서 30분간 끓인다. 이를 식힌 후 여과하여 여액이 산성이 나타나지 않을 때까지 충분히 씻고 씻은 액을 여액과 합하여 1N 수산화나트륨용액으로 중화한 다음 이를 시험용액으로 하여 0.05M 이.디.티.에이.용액 30mL, 암모니아․염화암모늄완충액 5mL 및 에리오크롬블랙시액 0.15mL를 가하고 액의 색이 청색이 될 때까지 0.05M 이.디.티.에이.용액으로 적정한다.
0.05M 이.디.티.에이.용액 1mL ＝ 2.015mg MgO
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정의
이 품목은 스테아린산 및 팔미틴산의 마그네슘염의 혼합물이다.
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개요
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.".
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화학적 성질
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.
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용도
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.
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정의
Mg(C18H35O2)2 or with one H2O.
Technical grade contains small amounts of the
oleate and 7% magnesium oxide, MgO.
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생산 방법
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.
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제조 방법
Magnesium stearate is created by the reaction of sodium stearate with magnesium sulfate.
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일반 설명
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.
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Pharmaceutical Applications
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.
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Safety Profile
Slightly toxic by
ingestion. Spontaneously combustible.
When heated to decomposition it emits
acrid smoke and toxic fumes.
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Safety
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
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저장
Magnesium stearate is stable and should be stored in a well-closed
container in a cool, dry place.
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비 호환성
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.
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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.
