Organic Synthesis Research Laboratory, Sumitomo Chemical Co. Ltd., 3-1-98, Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan.
J Pharm Biomed Anal. 2014 Jan;87:308-12. doi: 10.1016/j.jpba.2013.06.028. Epub 2013 Jul 3.
In the industry of fine chemicals, including pharmaceutical and agricultural chemicals, analytical tests are performed by production departments or contract research organizations at some stage in the research and development of products. These external organizations are required to maintain the capabilities to perform analytical tests using methods that are equivalent to or better than those specified by analytical method validation. For this reason, transfer of analytical procedures to an alternative site becomes necessary. In this review, the relationship between transfer of analytical procedures and assay validation is introduced, focusing on analytical procedures that include HPLC.
在精细化工行业（包括制药和农药化学）中，产品研发的某个阶段，生产部门或合同研究组织会进行分析测试。这些外部组织需要具备使用等效或优于分析方法验证规定方法进行分析测试的能力。因此，有必要将分析程序转移到替代地点。本文综述了分析程序转移与含量测定验证之间的关系，重点介绍了包含 HPLC 的分析程序。
