RLD Profile Comparison. Impurity detection at ppt level
Drug impurity profile is not a technique routine. So is the ideal project that a sponsor can externalize to specialized analytical contract laboratories.
We offer full control over the entire process of impurity identification, isolation and characterization.
Obtain relevant data, collect and interpret all physicochemical parameters and structural information needed to compile and submit an IND issue. Complete support for preparation of CMC, IND, ANDA. Support for API companies as well as Drug Products. Methods development and drug-excipient interaction.
Help costumers in the fine tuning of acceptance criteria and critical quality attributes: Identity, purity, quality, potency or strength and impurities during the course of product development.