Compendial & Non-Compendial Testing

Pharmacopeial monographs such as the US Pharmacopeia-National Formulary (USP/NF), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP) provide standardized methods and specifications for generic pharmaceutical raw material and finish products. Certificate of analysis (C of A) for raw material and products are provided.

Applications for Compendial Testing

Raw material testing (USP/NF, EP, JP, BP, etc)
ICH Stability Studies (raw material and finished products)
Dissolution studies
Particle Size Distribution determination
Assay and Stability indicating methods

We can follow your validated methods after transfer or validate in-house methods to perform a variety of tests.

Applications for Non-Compendial Testing

Method transfers or verification
Assay determination
Impurity identification
Stability studies and disintegration studies