A single HPIC method was developed and validated for the analysis of both [¹¹C]Choline and [¹³N]Ammonia with the same setup. The HPIC system suitability tests were performed and [¹¹C]Choline and [¹³N]Ammonia were used to verify their performance on this HPIC method. The HPIC setup and method provides qualitative and quantitative analysis information of [¹¹C]Choline and [¹³N]Ammonia. The data suggested this HPIC method is validated for determining radiochemical/chemical purity and radiochemical identity of [¹¹C]Choline and [¹³N]Ammonia products in CGMP compliant manufacturing process.

中文翻译：

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单一HPIC方法分析[ ¹¹ C]胆碱和[ ¹³ N]氨

开发了一种单一的HPIC方法，并通过相同的设置验证了该方法可用于[ ¹¹ C]胆碱和[ ¹³ N]氨气的分析。进行了HPIC系统适用性测试，并使用[ ¹¹ C]胆碱和[ ¹³ N]氨水验证了该HPIC方法的性能。HPIC设置和方法提供[ ¹¹ C]胆碱和[ ¹³ N]氨的定性和定量分析信息。数据表明，该HPIC方法经验证可用于确定符合CGMP要求的生产过程中[ ¹¹ C]胆碱和[ ¹³ N]氨产品的放射化学/化学纯度和放射化学特性。