Development of new analytical methods and their validation

 

SYNTH-INNOVE Laboratories quality department is supported by an experienced staff who have access to a large array of analytical instrumentation.

 

 


To support Registration, the analytical methods developed in our laboratories are validated according to international official standards (ICH, European or FDA guidelines).

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.



SYNTH-INNOVE Laboratories are equipped with a large array of state-of-the-art material. This equipment allows the performance of elaborated analytical techniques including the following method developments:

  • Purity tests 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
  • 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
  • Validation of analytical methods
  • APIs Polymorphism studies
  • Stability studies according ICH guidelines

The development and validation reports edited by SYNTH-INNOVE meet the ICH guidelines recommendations and satisfies the requirement for a DMF registration.

SYNTH-INNOVE Laboratories has more than 12 years experience in the constitution of registration files and an excellent expertise in meeting the requirements for European Registration.
All APIs Regulatory Documentations submitted to the authorities in Europe or in France by SYNTH-INNOVE laboratories were successfully registrated .