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Volume 28 Issue 1
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2010  >  28(1): 36-39

HU Yu-chi, YANG Yun-yun, ZHU Chun-yue, ZHOU Jian-ping. Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot[J]. Journal of Pharmaceutical Practice and Service, 2010, 28(1): 36-39.
Citation: HU Yu-chi, YANG Yun-yun, ZHU Chun-yue, ZHOU Jian-ping. Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot[J]. Journal of Pharmaceutical Practice and Service, 2010, 28(1): 36-39.
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Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot

  • Beijing Institute for Drug Control,Beijing 100035,China

  • Received Date: 2009-06-22
  • Rev Recd Date: 2009-11-08
  • Objective To confirm the feasibility of gelation method of bacterial edotoxins tests for goserelin acetate sustained-release depot. Methods Acetonitrile were added to dissolve the sustained-release depot,the goserelin acetate will been precipitated out.Then the suspension could been removed to pyrogen-free water,the goserelin acetate will been dissolved;the interference test of the dilute solution can be conducted,the endotoxin recovery tests of acetonitrile suspension was conducted also. Results 200-fold diluents of the acetonitrile suspension dose not interfere with the test for bacterial endotoxins.The endotoxin recovery of acetonitrile suspension was 25 percent to 35 percent.,thus should to decrease the endotoxin limit of the acetonitrile suspension. Conclusion Gelation clot test is suitable for the detection of Goserelin Acetate Sustained-Release Depot.
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Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot

  • Beijing Institute for Drug Control,Beijing 100035,China
  • Received Date: 2009-06-22
  • Rev Recd Date: 2009-11-08

Abstract: Objective To confirm the feasibility of gelation method of bacterial edotoxins tests for goserelin acetate sustained-release depot. Methods Acetonitrile were added to dissolve the sustained-release depot,the goserelin acetate will been precipitated out.Then the suspension could been removed to pyrogen-free water,the goserelin acetate will been dissolved;the interference test of the dilute solution can be conducted,the endotoxin recovery tests of acetonitrile suspension was conducted also. Results 200-fold diluents of the acetonitrile suspension dose not interfere with the test for bacterial endotoxins.The endotoxin recovery of acetonitrile suspension was 25 percent to 35 percent.,thus should to decrease the endotoxin limit of the acetonitrile suspension. Conclusion Gelation clot test is suitable for the detection of Goserelin Acetate Sustained-Release Depot.

HU Yu-chi, YANG Yun-yun, ZHU Chun-yue, ZHOU Jian-ping. Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot[J]. Journal of Pharmaceutical Practice and Service, 2010, 28(1): 36-39.
Citation: HU Yu-chi, YANG Yun-yun, ZHU Chun-yue, ZHOU Jian-ping. Study on gelation method of bacterial endotoxin test in goserelin acetate sustained-release depot[J]. Journal of Pharmaceutical Practice and Service, 2010, 28(1): 36-39.
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