소듐스테아릴푸마레이트

소듐스테아릴푸마레이트 속성

소듐스테아릴푸마레이트 C화학적 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.

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

소듐스테아릴푸마레이트 준비 용품 및 원자재

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소듐스테아릴푸마레이트 공급 업체

공급자	전화	이메일	국가	제품 수	이점
Wuhan Fortuna Chemical Co., Ltd	+86-27-59207850 +86-13986145403	info@fortunachem.com	China	5988	58
Shaanxi Dideu Medichem Co. Ltd	18192627656	1012@dideu.com	China	3422	58
Hebei Mojin Biotechnology Co., Ltd	+8613288715578	sales@hbmojin.com	China	12456	58
Hebei Yanxi Chemical Co., Ltd.	+8617531190177	peter@yan-xi.com	China	5993	58
Sigma Audley	+86-18336680971 +86-18126314766	nova@sh-teruiop.com	China	525	58
Ouhuang Engineering Materials (Hubei) Co., Ltd	+8617702722807	admin@hbouhuang.com	China	2259	58
Henan Tianfu Chemical Co.,Ltd.	+86-0371-55170693 +86-19937530512	info@tianfuchem.com	China	21691	55
Hangzhou FandaChem Co.,Ltd.	008657128800458; +8615858145714	fandachem@gmail.com	China	9348	55
ATK CHEMICAL COMPANY LIMITED	+undefined-21-51877795	ivan@atkchemical.com	China	32480	60
career henan chemical co	+86-0371-86658258	sales@coreychem.com	China	29914	58

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