Analysis method optimization and stability test of related substances of chloral hydrate
10.12206/j.issn.2097-2024.202106092
- VernacularTitle:水合氯醛有关物质分析方法优化与稳定性检测
- Author:
Kaichao SONG
1
;
Xiaqin FANG
1
;
He LI
1
;
Yumei HAO
1
;
Xiaochuan TAN
1
;
Wensheng ZHENG
1
Author Information
1. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key Laboratory of Drug Delivery Technology and Novel Formulation, Beijing 100050, China.
- Keywords:
chloral hydrate;
chloroform;
halogenated carboxylic acid;
related substances;
stability
- From:
Journal of Pharmaceutical Practice
2023;41(7):422-427
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a quality control method for detecting impurities in chloral hydrate raw materials, improve the quality standards and control limits of raw materials. Methods The determination methods of chloroform and halogenated carboxylic acid in chloral hydrate were established to monitor the change of impurities in chloral hydrate through stability. Results The research and establishment of chloroform and halogenated carboxylic acid methods met the requirements of relevant regulations for analytical methodology verification, which could accurately detect four impurities in raw materials and preparations by one method. Conclusion The study provides technical support for the improvement and optimization of the quality standards of chloral hydrate and preparations. It is very necessary to implement the impurity monitoring in preparation research and production process by the chloral hydrate impurity detection and the stability comparison of this product at high temperature and light, which could largely promote the safety of medication.
