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Solubility-Limited Impurity Purge in Crystallization

机译：溶解度 - 结晶中的杂质吹扫

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摘要

Crystallization from solution is a key unit operation utilized across the synthetic scheme to remove impurities. However, little is still known of the underlying impurity purge mechanisms that are responsible for controlling the final purity of the product. Reported herein is the solubility-limited impurity purge mechanism in which the impurity exists as a separate solid phase with its own solubility. A mathematical framework is presented that describes the separation of the impurity in the solid and liquid phases based on the relative solubilities of the product and impurity, and initial impurity level. Three theoretical solubility-limited impurity purge mechanisms are derived that are confirmed experimentally using salicylic acid, ibuprofen, and acetaminophen as model compounds. A practical experimental test is introduced that is used to identify if the impurity is rejected by solubility-limitation and its corresponding type. Finally, development strategies are presented to remove impurities that are purged based on their solubilities.
机译：来自溶液的结晶是在合成方案中使用的关键单元操作以除去杂质。然而，仍然已知是负责控制产品的最终纯度的底层杂质吹扫机制。本文报道的是溶解性限制杂质吹扫机制，其中杂质作为单独的固相，其具有自身的溶解度。提出了一种数学框架，其描述了基于产品和杂质的相对溶解度和初始杂质水平的固体和液相中的杂质分离。推导出三种理论上的溶解度限制杂质吹扫机制，其使用水杨酸，布洛芬和对乙酰氨基酚作为模型化合物来实验证实。引入了用于识别杂质是否通过溶解度限制拒绝的实际实验试验及其对应类型。最后，提出了发展策略以除去基于其溶解度清除的杂质。

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  • 来源
    《Nature reviews Cancer》 |2019年第2期|共11页
  • 作者

    Nordstrom Fredrik L.; Linehan Brian; Teerakapibal Rattavut; Li Huayu;

  • 作者单位

    Boehringer Ingelheim GmbH &

    Co KG API Engn Mat &

    Analyt Sci 900 Ridgebury Rd Ridgefield CT;

    Boehringer Ingelheim GmbH &

    Co KG API Engn Mat &

    Analyt Sci 900 Ridgebury Rd Ridgefield CT;

    Univ Wisconsin Sch Pharm 777 Highland Ave Madison WI 53705 USA;

    Boehringer Ingelheim GmbH &

    Co KG API Engn Mat &

    Analyt Sci 900 Ridgebury Rd Ridgefield CT;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 肿瘤学;
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