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Services

RLD Profile Comparison. Impurity detection at ppt level

Impurity Profiling

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.

 

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Isolation and characterization of impurities and degradation products.

N

Structure identification of unknown impurities.

N

Optimization of analytical methods for speed and selectivity.

Regulatory Support

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.

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Identity and Purity information (IR, HPLC, Mass Spectra). We can conduct complete characterization studies based on HPLC, Mass Spectra and Nuclear Magnetic resonance interpretation.The MS and NMR are executed by our operators in the laboratories of the STR of the UDG.

N

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.