Investigation for measuring the congealing temperature of benzyl benzoate in the Chinese pharmacopoeia pharmaceutical excipients
10.19778/j.chp.2024.03.015
- VernacularTitle:《中国药典》药用辅料苯甲酸苄酯凝点测定方法的研究
- Author:
Xiaoyue ZHU
1
;
Kai DU
;
Shimin YIN
;
Jie ZHENG
;
Qin HU
;
Lin WANG
Author Information
1. 北京市药品检验研究院(北京市疫苗检验中心),国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京 102206
- Keywords:
benzyl benzoate;
pharmaceutical excipient;
congealing temperature;
Chinese pharmacopoeia;
method study;
improvement recommendations
- From:
Drug Standards of China
2024;25(3):303-306
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the factors affecting and improvement recommendations about the congealing temperature of benzyl benzoate as pharmaceutical excipient by the method in the Chinese pharmacopoeia.Methods:The influence of seven factors such as measuring device,sample size,melting temperature,condensation tempera-ture,stop stirring time,stirring frequency and reading of congealing temperature on the determination of congealing temperature of benzyl benzoate was investigated.Results:The key factor for determination of benzyl benzoate con-gealing temperature was the stop stirring time,which was more reasonable when the sample temperature drops to constant or starts to rise slightly was reasonable.Conclusion:The improved method has better accuracy and repeat-ability,and is suitable for the measuring the congealing temperature of pharmaceutical excipient benzyl benzoate.
