小分子分析与质控(QC)
小分子方法开发和分析，包括药物化学、代谢物鉴定、杂质谱分析、药物代谢和药物代谢动力学，是制药QA/QC成功的关键。小分子药物成功的检验和放行依赖于高效的分析工具、验证指南和规范。小分子的分离和鉴定可采用多种不同方法，比如湿化学法、高效液相色谱(HPLC)、气相色谱(GC)、薄层色谱(TLC)、毛细管电泳(CE)、核磁共振波谱(NMR)和质谱法(MS)。
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