s
- 商品详情
- 生产商简介
-
通用名
BP: Sodium stearyl fumarate
PhEur: Natrii stearylis fumaras
USPNF: Sodium stearyl fumarate
别名
十八烷基富马酸钠；十八烷基反丁基酸钠；硬脂醇富马酸钠；十八醇富马酸钠； sodium octadecyl fumarate.
化学名和CAS注册号
2-Butenedioic acid , monooctadecyl ester, sodium salt（2-丁烯二酸单十八醇酯钠盐）[4070-80-8]
分子式 分子量
C22H39NaO4 390.5
制造工艺
以硬脂醇与马来酸酐反应。将该反应产物同分异构化继而成盐，即得硬脂富马酸钠。
类别
片剂和胶囊剂的润滑剂。
制剂应用
硬脂富马酸钠用作片剂和胶囊剂的润滑剂，浓度为0.5～2.0%w/）。它还被用于一些食品中。
性状
硬脂富马酸钠为白色细粉，并有扁平的球形颗粒的聚结物。
药典标准
见表I。
表I： 硬脂富马酸钠的药典标准。
测试项目
PhEur2002
USPNF20
鉴别
+
+
性状
+
-
含水量
≤5.0%
≤5.0%
铅
-
≤0.001%
重金属
-
≤0.002%
相关物质
+
-
硬脂马来酸钠
-
≤0.25%
硬脂醇
-
≤0.5%
皂化值（按无水物计算）
-
142.2～146.0
有机挥发性杂质
-
+
含量（按无水物计算）
99.0～101.5%
99.0～101.5%
一般性质
酸碱度： pH＝8.3（90℃， 5%w/v水溶液）。
密度：1.107g/cm3。
松密度：0.2～0.35 g/cm3
轻敲密度：0.3～0.5 g/cm3
熔点：224～245℃（伴有分解）
溶解度：见表Ⅱ。
比表面积：1.2~2.0m2/g。
表Ⅱ： 硬脂富马酸钠的溶解度
溶剂
20℃溶解度（除非另有说明）
丙酮
不溶
氯仿
不溶
乙醇
不溶
甲醇
微溶
水
25℃,1:2000
80℃,1:10
90℃,1:5
稳定性和贮藏条件
室温下，在带有聚乙烯螺旋盖的琥珀色玻璃瓶中硬脂富马酸钠可以保存三年。
大容量包装的硬脂富马酸钠应存于密闭容器中，置阴凉干燥处。
配伍禁忌
有报道，硬脂富马酸钠不能与醋酸氯己定配伍。
安全性
硬脂富马酸钠被用于口服制剂中，通常被认为无毒无刺激性。
硬脂富马酸钠在大鼠和狗体内的代谢研究表明：大约80%被吸收，35%被快速代谢。吸收的部分被水解为硬脂醇和富马酸，硬脂醇进一步氧化成硬脂酸。在狗体内，没被吸收的硬脂富马酸钠24小时内以原型的形式由粪便排泄。
硬脂醇和硬脂酸是很多食品中天然成分，而富马酸是机体组织正常成分。WHO已经审定过硬脂酸酯和枸橼酸硬脂酯。枸橼酸硬脂酯的可接受日常摄入量为50mg/kg体重。没有必要确定硬脂酸酯和富马酸日摄入量。
有报道，富马酸二钠比NaCl的毒性稍强。
进一步的资料参见富马酸，硬脂酸和硬脂醇。
操作注意事项
遵守材料操作的环境和数量相应的常规注意事项。硬脂富马酸钠应在通风处操作，建议戴护眼镜。
法规
已列入GRAS。FDA准许作为调节和稳定剂直接加入下列供人食用的食品中：各种烘烤食品，面粉稠化食品，烘干马铃薯及处理过的谷物，用量可占食品重量0.2～1.0%。在英国许可用于口服制剂。FDA收载入《非活性组分指南》（口服胶囊剂和片剂）中。
注释
市售商品为硬脂富马酸钠的纯品，当不太纯的硬脂酸酯类润滑剂有化学配伍禁忌而不适用时，就显示出硬脂富马酸钠的价值。其疏水性比硬脂酸镁或硬脂酸弱，且对片剂溶解的滞后效应比硬脂酸镁小。
硬脂富马酸钠的EINECS号为203-743-0。
-
NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) was found in 1991 as a small manufacturing unit has grown today into a dynamic production center for range of products finding applications in various Industry Verticals.
While achieving this growth we are still maintaining it as a family owned enterprise to make best of the advantages of being a closely held company.
15 years after its foundation the company has been able to adapt to the fast growing technological changes to have an edge in the global market place.
Our focus is on the customer and achieving the high degree of customer satisfaction by providing quality products at a reasonable cost backed by timely deliveries and after sales support.
In 1991 NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) was started to Manufacture Fine Chemicals for the Pharmaceutical and Allied Industries.
In 1993 received the Indian FDA Approval.
In 1996 the Production of Metallic Stearates was started utilizing the totally Home-Grown technologies.
In 2000 first Export for USA
n 2003 received ISO 9001:2000 from Bureau Veritas Quality International (Holding) S.A. London.
In 2005 we started building the plant as per WHO-GMP and US-FDA requirements and also received US-DMF no.18912 for our product Magnesium Stearate.
In 2006 we received KOSHER Certificate
In 2007 EDMF No.1252 from European authorities.
In 2008 received ISO 14001:2004.
In 2009 received WHO – GMP Approval.
NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) wishes to maintain a profitable competitive and continuing organization where challenging and rewarding environment encourages employees to work with pride, enthusiasm and commitment.
We acknowledge that the present and future well-being of the company and its employees depends on our pharmaceutical and chemical products meeting statutory, regulatory and customer requirements. We support this by implementing Good Manufacturing and good laboratory practices.
Why Nitika?
Only company in Asia and second in world have Active US-DMF No.18912 for Magnesium Stearate
All the major global players producing Magnesium Stearate are chemical companies having a small Pharma division where as NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) is a purely Pharma focused company and a step further we are focusing on only Pharmaceutical specialized Excipients.
Being strategically located in Central India, provides us with immense benefits like availability of pool of technically qualified personnel, low cost manpower, ready availability of various raw material and utilities.
We stand to gain from the fact that, India is being projected as the future pharmaceutical hub in the global knowledge economy.
India’s first International Multi-model Cargo Hub ‘MIHAN’ is coming up at a distance of about 15 miles from our plant.
Vision
We see Nitika Chemicals as a research based integrated chemical and pharmaceutical company of tomorrow having presence all over the globe with its focus on pharmaceutical excipients and specialties by providing its customers high quality products and backing them with technical, documentation and other supports.
