소듐스테아릴푸마레이트

한글명:소듐스테아릴푸마레이트

카스 번호4070-80-8

상품명:Sodium Stearyl Fumarate

CBNumberCB8725343

분자식C22H41NaO4

포뮬러 무게392.56

MOL 파일4070-80-8.mol

동의어(한글)

소듐스테아릴푸마레이트

화학적 성질

녹는점	>196°C (dec.)
저장 조건	Inert atmosphere,Room Temperature
용해도	물에 거의 녹지 않고, 메탄올에 약간 녹고, 아세톤과 무수 에탄올에 거의 녹지 않습니다.
물리적 상태	Solid
색상	흰색에서 황백색까지
InChIKey	GKCVIRALYIXVLE-RZLHGTIFSA-M
LogP	8.789 (est)

위험 및 안전 성명

위험품 표기

위험 카페고리 넘버

36/38

안전지침서

WGK 독일

HS 번호

2917191600

NFPA 704:

	1
2		0

그림문자(GHS)

소듐스테아릴푸마레이트 화학적 특성, 용도, 생산

개요
Sodium Stearyl Fumarate (SSF) is used as a lubricant in tableting to reduce the friction between the tablet and the die wall and to prevent adhesion of the material to punches or the die wall in the pharmaceutical industries. It is used also as a lubricant in the manufacturing of capsules and other oral dosage forms. Sodium stearyl fumarate is also used in food production as a dough conditioner, a conditioning agent, and a stabilizing agent.
화학적 성질
Sodium stearyl fumarate is a fine, white powder with agglomerates of flat, circular-shaped particles.
용도
Sodium Stearyl Fumarate is a dough conditioner and conditioning agent that is a white powder practically insoluble in water. It is used as a dough conditioner in yeast-raised baked goods. It is used as a conditioning agent in dehydrated potatoes. It also functions as a maturing and bleaching agent.
생산 방법
Stearyl alcohol is reacted with maleic anhydride. The product of this reaction then undergoes an isomerization step followed by salt formation to produce sodium stearyl fumarate.
일반 설명
Sodium Stearyl Fumarate is commonly used in tablet formulations as a lubricant and anti-adherent to improve powder flowability, reduce tablet sticking, and enhance the dissolution properties of the tablet.
Pharmaceutical Applications
Sodium stearyl fumarate is used as a lubricant in capsule and tablet formulations at 0.5–2.0% w/w concentration. It is also used in certain food applications.
Safety
Sodium stearyl fumarate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material.
Metabolic studies of sodium stearyl fumarate in the rat and dog indicated that approximately 80% was absorbed and 35% was rapidly metabolized. The fraction absorbed was hydrolyzed to stearyl alcohol and fumaric acid, with the stearyl alcohol further oxidized to stearic acid. In the dog, sodium stearyl fumarate that was not absorbed was excreted unchanged in the feces within 24 hours.
Stearyl alcohol and stearic acid are naturally occurring constituents in various food products, while fumaric acid is a normal constituent of body tissue. Stearates and stearyl citrate have been reviewed by the WHO and an acceptable daily intake for stearyl citrate has been set at up to 50 mg/kg body-weight. The establishment of an acceptable daily intake for stearates and fumaric acid was thought unnecessary.
Disodium fumarate has been reported to have a toxicity not greatly exceeding that of sodium chloride.
저장
At ambient temperature, sodium stearyl fumarate is stable for up to 3 years when stored in amber glass bottles with polyethylene screw caps.
The bulk material should be stored in a well-closed container in a cool, dry place.
비 호환성
Sodium stearyl fumarate is reported to be incompatible with chlorhexidine acetate.
Regulatory Status
GRAS listed. Permitted by the FDA for direct addition to food for human consumption as a conditioning or stabilizing agent in various bakery products, flour-thickened foods, dehydrated potatoes, and processed cereals up to 0.2–1.0% by weight of the food. Included in nonparenteral medicines licensed in the UK. Included in the FDA Inactive Ingredients Database (oral capsules and tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients.
참고 문헌
[1] Arne W. Hölzer and John Sjögren, Evaluation of sodium stearyl fumarate as a tablet lubricant, International Journal of Pharmaceutics, 1979, vol. 2, 145-153
[2] Holger Zorn and Peter Czermak, Biotechnology of Food and Feed Additives, 2014
[3] https://www.fda.gov

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