Compendial Testing

As a drug sponsor or applicant, 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 expertise, particularly in the areas of analytical chemistry and statistics, to ensure accurate and reliable results.

At Cambrex, 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), the Food Chemicals Codex (FCC), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), American Chemical Society (ACS), ISO/IEC 17025:2005 or to our clients’ defined specifications. We work with you to understand your testing challenges and develop and validate methods that meet your specific needs.