Study On The Feasibility Of The Method Test Of Ceftezole Sodium Pyrogen

Objective:①Study on the feasibility of bacteriam endotoxins test of Ceftezole Sodium. We will give the feedback information the producer that produce Ceftezole Sodium to purpose to improve its productive technology. At the same time, give the feedback information China Pharmacopoeia Committee and State Food and Drug Administration, so that they can gain the reference data about the quality of Ceftezole Sodium.②The experimental data will provides the help that revise the standards of People's Republic of China pharmacopoeia of 2010 edition. With the help of the China Pharmacopoeia Committee and the State Food and Drug Administration , the Bacterial Endotoxins Test will become the statutory method in the next version Pharmacopoeia to test bacterial endotoxins in Ceftezole Sodium. Each manufacturer can use it. Methods: We use the principle that TAL(Tachypleus Amebocyte Lysate,中国鲎试剂) can produce agglutination with the Bacterial Endotoxins to check Bacterial Endotoxins in Ceftezole Sodium. Results: The concentration of noninterference of Ceftezole sodium is 12.5 milligrams per milliliter. The amount of bacterial endotoxins in Ceftezole Sodium for Injection should be less than 0.15Eu for each milligrams. Conclusion: The Bacterial Endotoxins Test can be used to test bacterial endotoxins in Ceftezole Sodium. This method is sensitive, accurate and reliable, low-cost, more suitable for operation of the laboratory. Use of the method reflects that we can keep pace with the developed countries in the test means.