Drug Analysis

Shaza W. Shantier
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引用次数: 5

Abstract

Instrumental methods are widely used for the analysis and stability studies of compounds in bulk and pharmaceutical forms. They vary in their sensitivity, techniques and reagents involved. This chapter will overview those different techniques and the application of the analytical methods. It will also describe how to design and develop simple, sensitive and accurate method for routine quality control of specified compound depending on its molecular structure. Quality control and assurance of the analytical process will be discussed. Furthermore, the chapter will describe a number of factors affecting the chemical and physical stability of Pharmaceutical formulations and how to develop stability-indicating methods to qualify and quantify the drug degradation.
药物分析
仪器方法广泛用于原料药和药物形式的化合物分析和稳定性研究。它们在灵敏度、技术和所用试剂方面各不相同。本章将概述这些不同的技术和分析方法的应用。描述了如何根据特定化合物的分子结构设计和开发简单、灵敏、准确的常规质量控制方法。将讨论分析过程的质量控制和保证。此外,本章将描述影响药物制剂化学和物理稳定性的一些因素,以及如何开发稳定性指示方法来确定和量化药物降解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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