Acanthus Research Inc.

We manufacture and certify analytical standards of drug substances at any developmental stage. This includes identification, synthesis or isolation of process impurities, degradation products, metabolites and stable isotope labeled analogs for use as internal standards in bioanalysis.

We offer custom synthesis services of up to gram-quantities of materials for a wide range of industrial and academic customers.

We always respond quickly to inquiries. We listen to our customers and provide products that meet their specifications.

The purity of our products is supported by solid analytical data and their certification is tailored to our customer needs.

We specialize in chemical synthesis of metabolites of active pharmaceutical ingredients and their stable isotope labeled analogs (deuterium, carbon-13, nitrogen-15): glucuronides, sulfates, oxides, hydroxylated species, hydrolytic metabolites etc. From mg quantities to hundred mg quantities.

We specialize in developing stable isotope labeling strategies for new molecular entities and their relevant metabolites.

We offer studies for your process development projects, such as fate and purge studies for impurities, optimization of individual chemical steps, investigation of synthetic routes, isolation or synthesis and characterization of reference standards for your process impurities and intermediates, up to multi gram quantities, run-through of the whole synthesis with isolation of all relevant impurities. We develop analytical methods for testing of your intermediates, products, or in-process samples.

Laboratory scale non-GMP batch production for non-GLP studies. Up to 500 g scale.

Evaluation of chemical processes for the risk of potentially genotoxic impurities in the final product, developing control strategies, fate and purge studies for process impurities, developing strategies for control of elemental impurities as per the current guidelines.

Our state of the art analytical laboratory can develop reliable analytical methods for impurity quantitation in API intermediates, API's and finished dosage (stability indicating). We can support the analytical development with the in-house development of reference materials in our synthetic laboratories.