Drug impurity profile is not a routine technique. 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.
- Isolation and characterization of impurities and degradation products.
- Structure identification of unknown impurities.
- Optimization of analytical methods for speed and selectivity.
Impurity profiling can otherwise serve different purposes, for instance, establishing links between two or more samples, identifying or discarding synthetics routes, predicting toxicity, etc. We not only conduct for you the profile but help in the interpretation of the different scenarios.
Analytical Part of CMC for IND or NDA dossier elaboration
Obtain relevant data, collect and interpret all physicochemical parameters and structural information needed to compile and submit an IND issue
- Identity and Purity information (IR, HPLC, Mass Spectra). We can conduct complete characterization studies based on HPLC, Mass Spectra and Nuclear Magnetic resonance interpretation.
- Isomerism and polimorfism considerations
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.