The light stability of Ambroxol Hydrochloride Injection under different brown glass ampoules packaging
REN Chuan-jie
LI Kun-wei
HUANG Guo-ying
JIA Qing-qing
ZHANG Jian
Abstract：Objective To compare the stability of Ambroxol Hydrochloride Injection in different brown glass ampoule under the light test and determine the best form of packaging. Methods Through the light test,determining the ambroxol hydrochloride and impurities by HPLC,to study the stability of Ambroxol Hydrochloride Injection packaging by brown low &neutral borosilicate glass ampoule and carton. Results Ambroxol Hydrochloride Injection packaging by brown neutral boro-silicate glass ampoule was consistent with the low brown borosilicate glass ampoule and carton packaged under the light test. Ambroxol Hydrochloride Injection individually packaged by brown low borosilicate glass ampoule was significantly dif-ferent,and the unknown monoimpurity was over the reporting limits after 48 h exposured. Conclusion Brown neutral boro-silicate glass ampoule or low borosilicate glass ampoule and carton can be used as Ambroxol Hydrochloride Injection packa-ging materials,but light exposure time should not exceed 24 h for brown low borosilicate glass ampoule packaging Ambroxol Hydrochloride Injection.
Keywords：Brown glass ampouleAmbroxol Hydrochloride InjectionLight stability
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 461-463 )