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通用名
BP: Anhydrous calcium hydrogen phosphate
JP: Anhydrous dibasic calcium phosphate
PhEur: Calcii hydrogenophosphas anhydricus
USP: Dibasic calcium phosphate
化学名和CAS注册号
Dibasic calcium phosphate [7757-93-9]
分子式 分子量
CaHPO4 136.06
制造工艺
磷酸氢钙通常是由高纯度磷酸和氢氧化钙水混悬液按化学计量比反应制得，氢氧化钙可由石灰石制得(2) ，然后在一定温度下干燥，形成正确的含水状态。干燥后，粗制品可以通过分级装置得到粗颗粒，细粒可以另经粉碎制得。
类别
片剂和胶囊剂的稀释剂。
制剂应用
无水磷酸氢钙既可作为一种辅料，也可作为补钙营养品。由于其粗颗粒可压性和流动性好，它还可以应用于药物制剂中。粗颗粒状的无水磷酸氢钙最主要的形变机制为脆性断裂，从而降低了其应变的敏感性，使之更容易由实验室向工业生产应用转变。然而，与其二水合物不同，当它在较高压力下压片的时候，可以出现分层和顶裂。这种现象在它的用量占处方的大部分时，用深凹形冲头压片时明显地能观察到。这种现象与压紧度（rate of compaction）无关。
无水磷酸氢钙摩擦力较大，故压片时需加入润滑剂，例如1% w/w的硬脂酸镁或1% w/w的硬脂酸富马酸钠。
无水磷酸氢钙有两种不同粒径级别产品用于药剂工业中，经粉碎者可以用于经典的湿法制粒或干法制粒中，没有经粉碎者或较粗颗粒级别者可以用于直接压片。
无水磷酸氢钙不吸湿，在室温下稳定，不会被水化形成二水合物。
无水磷酸氢钙由于摩擦性好，还可用于牙膏和牙科用药处方中。
性状
无水磷酸氢钙是一种白色，无臭，无味的粉末或晶体。它以三斜晶系的晶体存在。
药典标准
见表Ⅰ
表Ⅰ： 无水磷酸氢钙在药典中的标准
测试项目
JP 2001
PhEur 2002 （suppl 4.1）
USP 25
鉴别
+
+
+
性状
+
+
–
灰分
–
–
6.6～8.5%
干燥失重
≤1.0%
≤2.0%
–
酸中不溶物
≤0.05%
–
≤0.2%
重金属
≤31 ppm
≤40 ppm
≤0.003%
氯化物
≤0.248%
≤330 ppm
≤0.25%
氟化物
–
≤100 ppm
≤0.005%
硫酸盐
≤0.200%
≤0.5%
≤0.5%
碳酸盐
+
+
+
钡
+
+
+
砷
≤2 ppm
≤10 ppm
≤3 ppm
挥发性有机物质
–
–
+
铁
–
≤400 ppm
–
含量测定（干燥质）
≥98.0%
98.0～101.0%
98.0～105.0%
一般性质
酸碱度：
pH=7.3（20 %浆液）
pH=5.1（20 %）
pH=6.1～7.2（5 %）
休止角：32o
密度：2.89 g/cm3
松密度：0.78 g/cm3
0.45 g/cm3
轻敲密度：0.82 g/cm3
0.46 g/cm3
熔点：不熔化；约在425℃降解形成焦磷酸钙。
含水量：0.1～0.2 %。这种无水物质仅有表面吸附的水分，不能再水化形成二水合物
粉末：平均粒径15μm
溶解度：几不溶于醚、乙醇和水；但溶于稀酸中。
比表面积：20～30 m2/g
35 m2/g
稳定性和贮藏条件
无水磷酸氢钙不吸湿，相对稳定。高湿条件下不会水化形成水合物。
散装料密闭保存于干燥处。
配伍禁忌
磷酸氢钙与四环素类抗生素有配伍禁忌。
粉碎的无水磷酸氢钙的表面是碱性的，因而它不能与那些对碱性pH值敏感的药物配伍使用。然而，有报告指出，粉碎的和未粉碎的无水磷酸氢钙其表面酸碱性不同；未粉碎的粒子表面呈酸性。这点对提高药物的稳定性非常有意义，特别是当改变制片工艺时，比如，由干法制粒压片到直接粉末压片其粒径应改变。
据报道，磷酸氢钙二水合物与很多药物和辅料有配伍禁忌；另见磷酸氢钙二水合物。
安全性
无水磷酸氢钙广泛应用于口服药物制剂、食品、牙膏，通常认为无毒、无刺激性。
注意事项
遵守材料操作的环境及数量相适应的注意事项。微细粉碎的颗粒可产生有害的粉尘，应使用防尘面罩或呼吸器。
法规
已列入GRAS。在欧洲准许作为食品添加剂，已收载于FDA《非活性组分指南》（口服胶囊和片剂）。欧洲允许用于非注射用制剂。
同类物质
Ca2HPO4·2H2O；Ca3(PO4)2
注释
磷酸钙的EINECS号为231-837-1。
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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.
