作为药物发起人或申请人, you are required to evaluate your drug substances and products according to standards in official compendia. A central challenge in compendial testing is the complexity and diversity of pharmaceutical compounds and the raw materials used in the process, which may require multiple methods or techniques to release them for clinical or commercial use. Compendial testing also requires significant resources and 专业知识, particularly in the areas of analytical chemistry and statistics, 确保结果准确可靠.
在国家授权正规彩票平台, our experts are highly skilled and equipped to analyze your raw materials using specifications that adhere to the quality standards of the United States Pharmacopeia/National Formulary (USP/NF), 食品化学品法典(FCC), 欧洲药典(EP), 日本药典(JP), 美国化学会(ACS), ISO/IEC 17025:2005 or to our clients’ defined specifications. We work with you to understand your compendial testing challenges and develop and validate methods that meet your specific needs.