Abstract��
OBJECTIVE To investigate the impurity profile of ceftizoxime sodium for injection and develop the impurity control strategy. METHODS Eight batches of ceftizoxime sodium for injection from different manufacturers were tested by UPLC. The major impurities were identified by UPLC-MS. RESULTS The number and amount of impurities detected by UPLC were more than those tested by statutory method. The impurity profile consisted of ceftizoxime isomers, ring-opening products and dimers. CONCULSION The impurities can originate from the process of synthesis of raw material, subpackage of preparation, transportation and storage. It is important to control the key technology indicators and environmental conditions.
YANG Qian-,
LI Wei-,
CAO Xiao-Yun- etc
.Impurity Profile Study of Ceftizoxime Sodium for Injection[J] Chinese Pharmaceutical Journal, 2014,V49(19): 1750-1754
2014, Vol. 49 
