安定性指標分析方法及苛酷試驗於製藥產業之應用

Application of Stability Indicating Method and Stress Test in Pharmaceutical Industry

鄭慧玲(Hui-Ling Cheng) ； 陳淑豐(Shu-Feng Chen)

《化學》 76卷1期 (2018/03) Pp. 53-59

https://doi.org/10.6623/chem.201803_76(1).007

摘要

安定性指標分析方法及苛酷試驗於新藥研發過程來說具有其重要指標意義，可藉由試驗了解藥品製程中副產物、賦形劑及降解物等不純物對藥品的影響，確保原料藥和製劑的純度與穩定性，分析結果同時作為藥物包裝及儲存評估之依據。製藥界中普遍性使用高效能液相層析法搭配光電二極體陣列或質譜偵測器，針對不純物進行定性及定量檢驗。本文回顧安定性指標分析方法開發及苛酷試驗於製藥產業中應用方式及情形。

關鍵字

安定性指標分析方法 ； 苛酷試驗 ； 原料藥 ； 劑型

並列摘要

This review summarizes application of stability indicating method and stress test in pharmaceutical industry. In process of new drug development, stability indicating method and stress test are very important for evaluating stability and shelf life. Stability indicating method is a validated analytical method for accuracy and precision measurement drug substance and drug products that free from process impurities, excipient, and degradation products. That could be utilized to monitor degradation results during stress test. Stress test is designed to determine degradation conditions for hydrolysis, oxidation, and photolysis. The results provide information for supporting identification of possible degradants, degradation pathways and intrinsic stability of drug molecule.

並列關鍵字

Stability indicating method ； Stress test ； Drug substance ； Drug product