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