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通用名
BP: Calcium hydrogen phosphate
JP: Dibasic calcium phosphate
PhEur: Calcii hydrogenophosphas dihydricus
USP: Dibasic calcium phosphate
化学名和CAS注册号
Dibasic calcium phosphate dihydrate [7789-77-7]
分子式 分子量
CaHPO4·2H2O 172 .09
制造工艺
磷酸氢钙通常由高纯度磷酸与氢氧化钙（由石灰石制得）按计量比在水混悬液中反应，随后在特定温度下干燥达到特定水合状态。干燥后经分级操作得到粗制品，通过研磨可得细粒径产品。
类别
片剂和胶囊剂的稀释剂
制剂应用
磷酸氢钙二水合物在片剂处方中广泛应用，既可以作为辅料，又可作为补钙营养品。它是营养保健食品中应用较广泛的原料之一。由于其粗颗粒可压性好，流动性好，因而也用于药物制剂中。粗颗粒状的磷酸氢钙二水合物最主要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。然而磷酸氢钙二水合物摩擦性强，压片时须使用润滑剂，例如含量为1 % w/w的硬脂酸镁或1 % w/w的硬脂酰富马酸钠。制药工业中应用的磷酸氢钙二水合物有二种粒径规格。磨细的产品主要用于湿法制粒或干法制粒,未研磨品或粗颗粒制品主要用于直接压片。
磷酸氢钙二水合物不吸湿，室温下稳定。但在一定的温度和湿度条件下，能在低于100℃的温度下失去结晶水。这种现象与特定包装和颗粒表面因为结晶水的失去形成水性干的颗粒层有关，似乎由高湿度引发，和磷酸氢钙二水合物颗粒附近的高浓度水蒸气也有关系。
因具有摩擦性，磷酸氢钙二水合物也用在牙膏和牙粉处方中。
性状
磷酸氢钙二水合物为白色，无臭，无味的粉末或结晶，以单斜晶系形式存在。
药典标准
见表Ⅰ。
表Ⅰ：磷酸氢钙二水合物的药典标准
测试项目
JP 2001
PhEur 2002 (增补本)
USP 25
鉴别
+
+
+
性状
+
+
–
炽灼残渣
–
–
24 .5～26.5 %
干燥失重
19 .5～22 .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
≤0.160 %
≤0.5 %
≤0.5 %
碳酸盐
+
+
+
钡
+
+
+
砷
≤2 ppm
≤10 ppm
≤3 ppm
挥发性有机杂质
–
–
+
铁
–
≤400 ppm
–
含量测定
≥98.0 %
98.0～105.0 %
98.0～105.0 %
一般性质
酸碱度： pH=7.4（20 %混悬液）
松密度：0.915 g/cm3
轻敲密度：1.17 g/cm3
真密度：2.389 g/cm3
流动性：27.3 g/s
11.4 g/s
熔点：低于100℃分解并失水
含水量：磷酸氢钙二水合物含有二分子结晶水，可在低于100℃温度下失去。
粒径分布：平均粒径180 μm
细粉：平均粒子直径9 μm
溶解度：几不溶于乙醇、醚、水；可溶于稀酸。
比表面积：0.44～0.46 m2/g
稳定性和贮藏条件
磷酸氢钙二水合物不吸湿，相对稳定，但在特定条件下会失去结晶水。大包装原料的贮藏以及含有磷酸氢钙二水合物的片剂的包衣与包装有关。
大包装原料应密闭保存于阴凉、干燥处。
配伍禁忌
磷酸氢钙二水合物不应与四环素类抗生素配伍。有报道称磷酸氢钙二水合物与吲哚美辛、阿司匹林、阿斯巴甜、头孢氨苄、氨苄西林、红霉素有配伍禁忌。磷酸氢钙二水合物表面呈碱性，因而不宜与对碱敏感的药物合用。
安全性
磷酸氢钙二水合物在口服制剂、食品、牙膏中广泛应用，通常认为其无毒、无刺激性，但口服大量本品可能导致腹部不适。
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。本品细粉易产生有害粉尘，需佩戴防毒或防尘面具。
注释
已列入GRAS。在欧洲许可作为食品添加剂。已收载于FDA《非活性组分指南》（口服胶囊和片剂]。欧洲收载作为非注射用药物。
同类物质
无水磷酸氢钙；磷酸钙。
注释
由于磷酸氢钙二水合物不可逆地脱水生成无水化物，磷酸氢钙二水合物含量较高的处方在高温下进行稳定性加速实验会得出错误结果。这个现象能够在温度于40℃，贮藏6周后被观察到，这取决于包装形式和片剂包衣与否。磷酸氢钙二水合物在片剂中含量不高时，该效应就不易观察到。
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.