Analytical development

The development of new methods of analysis, their validation, the elaboration of registration dossiers (ASMF, IND, AMM, NDA)

Analytical development and regulatory support

SYNTH-INNOVE Laboratories quality department staff has an extensive expertise in the development of new analytical methods and a good experience in the constitution of registration files.

A large array of state-of-the-art material

Purity testing by HPLC with UV-VIS, refractometric or fluorimetric detection

HPLC or GC assay methods

Titration assay methods

GC methods for the quantitation of residual solvents

Study of impurity profile by HPLC-MS or GC-MS

Structure elucidation of degradation products by Mass spectrometry

Impurities traces quantitation by HPLC with chemical derivatization

Separation of enantiomers by HPLC (Chiral chromatography)

Analysis of amino-acids by HPLC with fluorimetric detection

Molecular weight distribution of polymers by SEC