Selection and strategy of water determination methods in pharmaceuticals
10.11665/j.issn.1000-5048.20220117
- VernacularTitle:药品水分测定方法的选择及策略
- Author:
Hao ZHOU
1
;
Huijie WANG
;
Yuanyuan ZHAO
;
Huan WANG
;
Shibo ZHANG
Author Information
1. 正大天晴药业集团股份有限公司
- Publication Type:Journal Article
- Keywords:
water determination methods;
drug;
sample structure;
solubility;
water content
- From:
Journal of China Pharmaceutical University
2022;53(1):113-119
- CountryChina
- Language:Chinese
-
Abstract:
Water content determination is an important aspect of quality research in the whole process of pharmaceutical development, production, storage and use.Therefore, it is significant to develop an accurate and robust method for the determination of water content in the quality control of pharmaceuticals.In this article, the selection and strategy for the study of water determination methods are explained on the basis of general water determination principles and application examples in Chinese and foreign pharmacopoeias, together with the analysis of sample structure, solubility and water content.This article aims to provide basis for the development of moisture testing methods and formulation of proper quality standards for pharmaceuticals.
