Famotidine for Injection Sterile Test.docVIP

 PAGE \* MERGEFORMAT 7 Famotidine for Injection Sterile Test [Abstract] Objective: To validate the sterility test with famotidine injection method. Methods: This study used the Chinese Pharmacopoeia 2005 Edition 2 (with admission Ⅺ H) contained in the ‘sterile Inspection Act’ under the experiment. Results: The sample tube sterile growth of 6-positive bacteria grow well. Conclusion: The methodology validation, the method is accurate and reliable, can be used as sterile injectable famotidine Inspection Act. [Keywords:] Injection Famotidine sterility test method (membrane filtration method) method validation Verification for Sterility Test of Famotidine for Injection LiYan JiangLi PeiMingRi (Jinlin prouincia Institute for food and Drug Control 132011) [Abstract] Objective: To verisy the sterility test of Famotidine for Injection.Method: Verification test in Pharmacopeia of PRChina (Chp) 2005 was used.Resuly: All of six strains positove control tubes reveal growth of micro-organism and the substance control gives no evidence of growth.Conclusion: this method is accurate.It can be used for sterility test of Famotidine for Injection. [Keywords:] Famotidine for Injection; Test of sterility (Membrane filtration method); testing and verifying of the method Famotidine injection is a kind of Gua base Thiazole of the H2 receptor antagonist, on gastric acid secretion significantly inhibited. On the market is very large, to ensure the safety of clinical medicine, the Chinese Pharmacopoeia 2005 Edition 2 provides sterility test to be done. This study was designed according to Chinese Pharmacopoeia 2005 Edition 2 contained in the sterility test method (with admission Ⅺ H) the establishment of Famotidine Injection sterility test method. 1 Materials and reagents 1.1 for the test materials Famotidine Injection (specification: 20mg / Extension, Lot No.: 060,103, Manufacturer: Shanxi Combo Biological Products Co., Ltd.). 1.2 medium and rinse solution Sterility test