Automated Measurement of Metastable Zones for Pharmaceutical Compounds

Automated Measurement of Metastable Zones for Pharmaceutical Compounds
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药物化合物亚稳区的自动测量

DOI:
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发表时间:
2003
期刊:
影响因子:
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通讯作者:
R. Colling
R. Colling
中科院分区:
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文献类型:
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作者:
A. R. Parsons;S. Black;R. Colling

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在开发用于制造药物化合物的结晶工艺时,了解晶体在什么条件下会生长而不会成核是很重要的。由于冗长和人员密集的技术,这些数据往往无法获得。为了鼓励在开发计划中使用这些数据,提出了一种自动确定亚稳区的方法。这种方法结合了浊度计和自动化实验室反应器的使用。通过重现硝酸钾溶解度曲线,验证了自动化方法的有效性,并对浊度计灵敏度的影响进行了研究。然后,该方法成功地用于测量药物中间体的亚稳区,从而提供有用的信息,以帮助开发该化合物的结晶过程。
It is important to know under what conditions crystals will grow but not nucleate when developing crystallization processes for the manufacture of pharmaceutical compounds. Owing to lengthy, personnel-intensive techniques, this data is often not available. In order to encourage the use of such data in the development programme an automated method of metastable zone determination is proposed. This method combines the use of a turbidity meter with an automated laboratory reactor. The validity of the automated method has been shown by reproducing a solubility curve for potassium nitrate, and in addition the effect of the turbidity meter sensitivity was studied. The method was then used successfully to measure the metastable zone for a pharmaceutical intermediate, thus providing useful information to aid the development of the crystallization process for that compound.