(1. <>National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, <>China ; 2. <>Shanxi Institute for Drug Control, Taiyuan 030001, <>China
Abstract��
OBJECTIVE To develop the impurity control strategy of amoxicillin/potassium clavulanate. METHODS The impurity profiling changes of amoxicillin plus potassium clavulanate were compared with both amoxicillin and potassium clavulanate alone by HPLC. RESULTS Not only some new impurities were found. Both the impurities produced by amoxicillin or by potassium clavulanate in the complex medicine increased more quickly than in the antibiotics alone with acceleration test. CONCLUSION The results indicated that the impurity profiling of a complex medicine composed by b-lactam antibiotics and b-lactam inhibitor was not a simple mixture of both the components alone. The research should be focused on the interaction among the components influencing upon the impurity profiling of the complex medicine.
ZHOU Xiao-xi,
GU Li-su
. Impurity Profiling Changes of Amoxicillin/Potassium Clavulanate[J] Chinese Pharmaceutical Journal, 2009,V44(23): 1821-1824
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[1]
INTERNATIONAL CONFERENCE ON HARMONIZATION OF TECHNICAL REQUIREMENTS FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE . Q 3A (R2) �� Impurities in New Drug Substances [J/OL] . ICH,<> Geneva <> , 2006 [ 2008-5-2 ]. http �� // ww w .ich.org .
[2]
ZHOU X X, GU L S, PANG H H, <>et al. Comparative studies on determination of related substances of amoxicillin-potassium clavulanate and its preparations [J]. <>Chin J Antibiotics( �й���������־ ) �� 2005 �� 30 �� 12 ���� 737-740.
2009, Vol. 44 
