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  1. Development and Validation of Microbial Test/Sterility Test Method_Analytical Development and Quality Study_CMC Study_Service_Bostal Drug Delivery Co., Ltd. EN
    2. EN 中文
Development and Validation of Microbial Test/Sterility Test Method_Analytical Development and Quality Study_CMC Study_Service_Bostal Drug Delivery Co., Ltd.

Service

Service

CMC Study Manufacture Preclinical Study Clinical Study Drugs Registration

Development and Validation of Microbial Test/ Sterility Test Method

 

We can provide the development and validation of microbial limit testing methods for non-sterile products. In accordance with ChP<1105><1106><1107>and USP<61><62>, and check the applicability of the developed methods to establish reliable and practical test methods, mainly applied to the test of total aerobic microbial count, total mold and yeast and related specified microorganisms for all non-sterile pharmaceutical dosage forms. For sterile products, we can provide sterility test, bacteriostatic efficacy , bacterial endotoxin test and relevant test.