• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国卫生研究院文献>AAPS PharmSciTech >Influence of Microenvironment pH Humidity and Temperature on the Stability of Polymorphic and Amorphous Forms of Clopidogrel Bisulfate
【2h】

Influence of Microenvironment pH Humidity and Temperature on the Stability of Polymorphic and Amorphous Forms of Clopidogrel Bisulfate

机译：微环境的pH湿度和温度对硫酸氢氯吡格雷多晶和无定形形式稳定性的影响

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

The effect of microenvironment pH, humidity, and temperature was evaluated on the stability of polymorphic and amorphous forms of clopidogrel bisulfate, when present alone or in combinations. Oxalic acid and sodium carbonate were used as solid stressors to create acidic and alkaline pH, respectively. The samples without and with stressors were subjected for 3 months to (1) 0% RH, 25% RH, 75% RH, and 85% RH at 40°C and also to (2) 60°C, 80°C, and 100°C at 0% RH. In case of solid samples without stressors, the mixture of polymorphic and amorphous forms showed more degradation than the individual forms above critical relative humidity (85% RH). Similar higher degradation was observed between 75% RH and 85% RH in case of acid-stressed samples. In alkaline microenvironment, all the samples showed identical decomposition attributed to conversion of bisulfate salt to free base. Thermal studies indicated that polymorphic forms of clopidogrel bisulfate and also its glassy amorphous form were highly resistant to temperature, whereas the rubbery state of the drug degraded significantly at temperatures of ≥80°C.
机译：单独或组合使用时，评估了微环境pH，湿度和温度对硫酸氢氯吡格雷多晶和无定形形式稳定性的影响。草酸和碳酸钠分别用作固体压力源，以产生酸性和碱性pH。在40°C和40°C下分别对（1）0％RH，25％RH，75％RH和85％RH以及（2）60°C，80°C和相对湿度为0％时为100°C。在没有应力源的固体样品的情况下，多晶型和无定形形式的混合物在临界相对湿度（85％RH）以上显示出比单个形式更大的降解。在酸应力样品的情况下，在75％RH和85％RH之间观察到类似的更高降解。在碱性微环境中，所有样品均显示出相同的分解，这归因于硫酸氢盐向游离碱的转化。热学研究表明，硫酸氢氯吡格雷的多晶型形式及其玻璃态无定形形式对温度具有高度抵抗力，而该药物的橡胶态在≥80°C的温度下会明显降解。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
代理获取

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号