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通用名
BP: Zinc stearate
PhEur: Zinci stearas
USP: Zinc stearate
别名
十八酸锌； zinc octadecanate
化学名和CAS注册号
Octadecanoic acid zinc salt（十八酸锌盐） [557-05-1]
分子式 分子量
C36H70O4Zn 632.33（以纯品计）
USP 25将硬脂酸锌描述为从脂肪中获得的固态有机酸混合物与锌的化合物，主要由各种比例的硬脂酸锌和棕榈酸锌组成。本品所含的锌相当于12.5～14.0%氧化锌（ZnO）。
PhEur 2002规定，硬脂酸锌[(C17H35COO)2Zn]可以含有各种比例的棕榈酸锌[(C15H31COO)2Zn]和油酸锌[(C17H33COO)2Zn]，以及10.0%～12.0%的锌。
制造工艺
将硫酸锌水溶液加入到硬脂酸钠溶液中，使生成的硬脂酸锌沉淀，用水洗涤并干燥。硬脂酸锌也可以用硬脂酸和氯化锌制备。
类别
片剂和胶囊的润滑剂。
制剂应用
硬脂酸锌在药物制剂中主要用作片剂和胶囊剂的润滑剂，其浓度最大可达1.5% w/w。本品也曾在化妆品和药用乳膏中用作增稠剂和遮光剂，还可被用作扑粉。见表I。
表Ⅰ 硬脂酸锌的用途
用途
浓度 / %
片剂润滑剂
0.5～1.5
疏水性软膏
2.5
性状
硬脂酸锌为白色、疏松的疏水性细微粉末，无砂砾感，微具特臭。
药典标准
见表II。
表Ⅱ 硬脂酸锌的药典标准
测试项目
PhEur 2002
USP 25
鉴别
+
+
性状
+
－
酸碱度
+
－
碱金属和碱土金属
－
≤1.0%
溶液外观
+
－
脂肪酸的酸值
195～210
－
脂肪酸溶液的外观
+
－
砷
－
≤1.5 ppm
镉
≤5 ppm
－
铅
≤25 ppm
≤0.001%
氯化物
≤250 ppm
－
硫酸盐
≤0.6%
－
有机挥发性杂质
－
+
含量测定（以锌计）
10.0～12.0%
－
含量测定（以氧化锌计）
－
12.5～14.0%
一般性质
自燃温度：421℃
密度：1.09 g/cm3
松密度：标准级别为0.26 g/cm3
闪点：277℃
熔点：120～122℃
粒度分布：100%通过44.5 μm的筛（#325筛网）。
溶解度：几乎不溶于乙醇（95%）、乙醚和水，溶于苯。
稳定性和贮藏条件
硬脂酸锌性质稳定，应置于密闭容器中，贮存于阴凉、干燥处。
配伍禁忌
硬脂酸锌遇稀酸分解。
安全性
硬脂酸锌用在口服和局部药物制剂中，通常被认为无毒、无刺激性。但是，吸入本品可导致致死性肺炎，尤其常见于婴儿。因此，当今的婴儿爽身粉中不再加入硬脂酸锌。
LD50（大鼠，腹腔注射）：0.25 g/kg
操作注意事项
遵守材料操作的环境和数量相适应的注意事项。建议使用护眼镜和手套。吸入硬脂酸锌对身体有害，应在通风良好的环境中操作，建议佩戴口罩。英国规定了长期（8h TWA）职业性地接触硬脂酸锌的极限浓度，即可吸入的粉尘为10 mg/m3，可呼吸的粉尘为4 mg/m3。短期（15min）接触的限度可吸入的粉尘为：20 mg/m3。
受热分解时，硬脂酸锌散发出刺鼻的氧化锌烟雾。
法规
已列入GRAS。FDA《非活性组分指南》中收载（口服胶囊剂和片剂）。在英国，许可用于非注射用制剂。
同类物质
硬脂酸钙；硬脂酸镁；硬脂酸。
注释
硬脂酸锌的EINECS号为209-151-9。
更多的资料请参阅硬脂酸镁。
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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.
