Delving into the Latest Updates on 大道隆达（北京）医药科技发展有限公司 with Synapse

概览

疾病领域	数量

神经系统疾病	1

排名前五的药物类型	数量

中药	1

关联

1

项与大道隆达（北京）医药科技发展有限公司相关的药物

Dengzhan Danqi Capsule

灯盏丹芪胶囊

靶点-

作用机制-

在研机构

大道隆达（北京）医药科技发展有限公司

原研机构

大道隆达（北京）医药科技发展有限公司

在研适应症

动脉粥样硬化 [+1]

非在研适应症-

最高研发阶段临床3期

首次获批国家/地区-

首次获批日期-

10

项与大道隆达（北京）医药科技发展有限公司相关的临床试验

CTR20132857 / Recruiting

群多普利胶囊用于高血压治疗的有效性及安全性的多中心、随机、双盲双模拟、阳性药对照临床试验

评价群多普利胶囊用于高血压治疗的有效性与安全性

开始日期2014-03-06

申办/合作机构

大道隆达（北京）医药科技发展有限公司

CTR20140154 / Completed临床2期

伊潘立酮片治疗精神分裂症的有效性和安全性的多中心、随机、双盲双模拟、利培酮片平行对照临床试验

以利培酮片为对照，评价伊潘立酮片治疗精神分裂症的有效性及安全性

开始日期2014-02-22

申办/合作机构

大道隆达（北京）医药科技发展有限公司

CTR20132389 / Completed临床1期

伊潘立酮片人体药代动力学试验

研究伊潘立酮片在中国健康人体内的药代动力学特性.

开始日期2014-01-08

申办/合作机构

大道隆达（北京）医药科技发展有限公司

100 项与大道隆达（北京）医药科技发展有限公司相关的临床结果

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0 项与大道隆达（北京）医药科技发展有限公司相关的专利（医药）

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1

项与大道隆达（北京）医药科技发展有限公司相关的文献（医药）

2015-07-01·Talanta2区 · 化学

Development and validation of a novel stability-indicating HPLC method for the quantitative determination of eleven related substances in ezetimibe drug substance and drug product

2区 · 化学

Article

作者: Yang, Wenning ; Wang, Guopeng ; Hou, Chengbo ; Yang, Ruirui ; Zhou, Huaming ; Luo, Zhiqiang ; Liu, Yang ; Deng, Zhongqing ; Tang, Minming

Ezetimibe is a novel lipid-lowering agent that inhibits intestinal absorption of dietary and biliary cholesterol. In the present work, a simple, sensitive and reproducible gradient reverse phase high performance liquid chromatographic (RP-HPLC) method for separation and determination of the related substances of ezetimibe was developed and validated. Eleven potential process-related impurities (starting materials, (3S,4S,3'S)-isomer, degradants and byproducts) were identified in the crude samples. Tentative structures for all the impurities were assigned primarily based on comparison of their retention time and mass spectrometric data with that of available standards and references. This method can be applied to routine analysis in quality control of both bulk drugs and commercial tablets. Separation of all these compounds was performed on a Phenomenex Luna Phenyl-Hexyl (100mm×4.6mm, 5μm) analytical column. The mobile phase-A consists of acetonitrile-water (pH adjusted to 4.0 with phosphoric acid)-methanol at 15:75:10 (v/v/v), and mobile phase-B contains acetonitrile. The eluted compounds were monitored at 210nm. Ezetimibe was subjected to hydrolytic, acid, base, oxidative, photolytic and thermal stress conditions as per ICH serves to generate degradation products that can be used as a worst case to assess the analytical method performance. The drug showed extensive degradation in thermal, acid, oxidative, base and hydrolytic stress conditions, while it was stable to photolytic degradation conditions. The main degradation product formed under thermal, acid, oxidative, base and hydrolytic stress conditions corresponding to (2R,3R,6S)-N, 6-bis(4-fluorophenyl)-2-(4-hydroxyphenyl)-oxane-3-carboxamide (Ezetimibe tetrahydropyran impurity) was characterized by LC-MS/MS analysis. The degradation products were well resolved from the main peak and its impurities, thus proved the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness.

100 项与大道隆达（北京）医药科技发展有限公司相关的药物交易

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100 项与大道隆达（北京）医药科技发展有限公司相关的转化医学

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