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Radiolysis of Solid-State Drugs and the Analytical Tools Applicable to this Study

机译:固态药物的放射分解及适用于本研究的分析工具

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摘要

The use of ionizing irradiation is a technique recommended by the Pharmacopoeias to sterilise solid-state drugs.Its high efficiency (Security Assurance Level of 10'6) combined to a limited rise of temperature make it the next best choice after heat techniques.Its main drawback lies in the production of unique impurities in small quantities.These products have been investigated through various analytical techniques,which are described and compared in this review.On the contrary of the irradiation of food,no protocols are defined yet.Analyses are though necessary either to determine the feasibility of the radiosterilization or to control the quality of the irradiated drug and common procedures should be established.In this perspective,we will therefore conclude by characterising the most appropriate methods.
机译:药典推荐使用电离辐射对固态药物进行灭菌的技术,其高效率(安全保证等级为10'6)加上有限的温度升高使其成为继加热技术之后的下一个最佳选择。缺点在于产生少量的独特杂质。这些产品已通过各种分析技术进行了研究,在本综述中进行了描述和比较。与食品辐照相反,尚未定义方案。尽管有必要进行分析为了确定放射灭菌的可行性或控制辐照药物的质量,应建立通用程序。在这种观点下,我们将总结最合适的方法。

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