Compendial tests are performed to determine if the material’s specifications are met and/or to address anticipated regulatory concerns. These test series can also be applied to determine general drug compatibility or for routine quality control.
Pharmacopeial monographs such as the US Pharmacopoeia-National Formulary (USP/NF), the European Pharmacopoeia (EP) the Japanese Pharmacopoeia (JP), and the British Pharmacopeoeia (BP) provide standardized methods and specifications for generic pharmaceutical raw material finish products. Nelson Laboratories can perform analysis of compendia release testing for raw materials and drug products on a daily basis in order to meet specifications.
If you would like to know more about compendial testing and its regulations, read our brochure.