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- 商品详情
- 生产商简介
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通用名
BP: Calcium stearate
JP: Calcium stearate
PhEur: Calcii stearate
USPNF: Calcium stearate
别名
十八酸钙；calcium octadecanate
化学名和CAS注册号
Octadecanoic acid calcium salt [1592–23–0]
分子式 分子量
C36H70CaO4 607.03 [纯物质]
PhEur 2002版收载的硬脂酸钙是一种由多种脂肪酸的钙盐组成的混合物，其中主要为硬脂酸钙[(C17H35COO)2Ca]和棕榈酸钙[(C15H31COO)2Ca],还有少量其他脂肪酸的钙盐，其中平均含有9.0～10.5%的氧化钙。
制造工艺
由氯化钙与硬脂酸和棕榈酸钠盐的混合物反应生成，用水洗涤去除氯化钠得到硬脂酸钙。
类别
片剂和胶囊剂的润滑剂
制剂应用
硬脂酸钙在药物制剂中的应用是作为片剂和胶囊剂的润滑剂，浓度不超过1.0% w/w，尽管它有很好的抗黏着性和润滑性，但其助流性较差。
硬脂酸钙亦可用作乳化剂、稳定剂和助悬剂，以及化妆品和食品的添加剂。
性状
硬脂酸钙是白色到黄色的细微膨松粉末，微有特臭，手感滑腻，无沙砾感。
药品标准（见表Ⅰ）
表Ⅰ：硬脂酸钙药品标准
测试项目
JP 2001
PhEur 2002
USPNF 20
鉴别
+
+
+
性状
–
+
–
微生物限度
–
1000/ g
–
酸碱度
–
+
–
干燥失重
≤4.0%
≤6.0%
≤4.0%
砷
≤2 ppm
–
–
重金属
≤20 ppm
–
≤10 ppm
氯化物
–
≤0.1%
–
硫酸盐
–
≤0.3%
–
镉
–
≤3 ppm
–
铅
–
≤10 ppm
–
镍
–
≤5 ppm
–
挥发性有机杂质
–
–
+
含量测定（CaO）
–
–
9.0～10.5%
含量测定（Ca）
6.4～7.1%
6.4～7.4%
–
一般性质
酸值：191～203
灰分：9.9～10.3%
氯化物：＜200 ppm
松密度和轻敲密度：见表Ⅱ
表Ⅱ：硬脂酸钙的松密度和轻敲密度
松密度（g/cm3）
轻敲密度（g/cm3）
生产厂A
标准法
–
0.26
A
–
0.45
AM
–
0.33
生产厂B
EA
0.21
0.27
熔融法
0.38
0.48
沉淀法
0.16
0.20
真密度：1.064～1.096 g/cm3
流动性：21.2～22.6%（Carr压缩性指数）
游离脂肪酸：0.3～0.5%
熔点：149～160℃
含水量：2.96%
粒径分布：1.7～60 μm；100%通过73.7 μm(200目筛)；99.5%通过44.5 μm（325目筛）。
剪切力：14.71 MPa
溶解度：几不溶于95%乙醇、乙醚和水中
比表面积：4.73～8.03 m2/g
硫酸盐：＜0.25%
稳定性和贮藏条件
硬脂酸钙性质稳定，应密闭贮藏在阴凉干燥处。
安全性
硬脂酸钙用于口服制剂中，通常认为无毒、无刺激性。
操作注意事项
遵守材料操作的环境及数量相适应的注意事项。硬脂酸钙应在通风良好处操作，注意保护眼睛，并佩戴手套和口罩。
法规
列入GRAS。收载于FDA《非活性组分指南》（口服胶囊和片剂）。英国允许用于非注射用制剂。
同类物质
硬脂酸镁；硬脂酸；硬脂酸锌。
注释
详细内容参见硬脂酸镁。
硬脂酸钙的EINECS号为216-472-8
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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.
