Quality under control
at every step of  production
 

Quality control of reagents, intermediates and finished products is performed according to Eur./US Pharmacopoeia.

 

 

GMP compliance and full traceability are guaranteed even on small quantities of substances.

Quality control
in accordance with cGMP





Quality control is performed by SYNTH-INNOVE Laboratories in accordance with GMP standards using state-of-the-art instrumentation and technology.



SYNTH-INNOVE Laboratories quality department is supported by an experienced staff and have access to the latest analytical instrumentation:

  • HPLC with diode array, refractive index or fluorimetric detection
  • Gas Chromatograph with FID detection
  • Mass spectrometer coupled to HPLC
  • Fourier transform infrared spectrophotometer
  • Potentiometric titrator
  • Polarimeter (sodium and mercury wavelengths)
  • UV-VIS spectrophotometer
  • Granulometer
  • Visible microscope
  • pH meter and conductimeter
  • Flame photometer (for Na+, K+, Li+ quantitation)
  • Karl-Fisher titrator (water micro-titration)
  • Melting point apparatus
  • 1H and 13C Nuclear Magnetic Resonance

The Quality Control is performed at all stages of production in accordance with Eur./US Pharmacopoeia using qualified Chemical Reference Substances for the performance of the assays as for the quantitation of impurities.

Raw materials, intermediates of synthesis and final products have to comply with pre-defined specifications.

Before its release is authorized, every product is analysed and maintained in a quarantine status until its analytical data and Certificates of Analysis are reviewed and accepted.