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China/Asia On Demand
Journal Articles
Evaluation on rationality of the existing quality and formulation of domestic sodium cefamandole nafate for injection
Pages: 476-480
Year: Issue:  6
Journal: Chinese Journal of Antibiotics

Abstract: Objective To evaluate the quality situation and formulation rationality of domestic cefamandole nafate for injection.Methods The products on the domestic market were inspected by the current statutory standard.The key test data,stability,clinical adverse events and other index of different formulated preparations were comparatively analyzed.Results The solid stability of different formulated preparations of cefamandole nafate for injection had no significant differences.After the solution was made,the initial pH of the solution containing sodium carbonate was slightly higher,the hydrolysis rate was relatively fast,and the rate of impurity increase was relatively fast,but the difference was not very obvious.The clarity of preparation contained sodium carbonate is not easy to change.Conclusion Cefamandole nafate for injection should be added a certain proportion of sodium carbonate to ensure the safety of products,but the most domestic products are direct packaging of cefamandole nafate.This formulation is not reasonable.
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