Quality Control
A quality control performed in compliance with European and US Pharmacopoeias
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.
Quality department have access to the latest up-to date analytical instrumentation
HPLC with diode array, refractive index or fluorimetric detection
Gas Chromatograph with FID and Mass detection
HPLC coupled to Mass spectrometry
Fourier transform infrared spectrophotometer
Potentiometric titrator
Polarimeter (sodium and mercury wavelengths)
UV-VIS spectrophotometer
Granulometer
Video and camera microscope
pH-meter and conductimeter
Flame photometer (for Na+, K+, Li+ quantitation)
Karl-Fisher titrator (water micro-titration)
Melting point apparatus
Proton and Carbon 13 Nuclear Magnetic Resonance
Achievement of Quality Control
The Quality Control is performed at all stages of production in accordance with Eur./US Pharmacopoeia using qualified Chemical Reference Substances for the achievement 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.