Quality > Quality Control

State of the art analytical research laboratories to assure material quality and management of the analytical records.

F.I.S. has internal labs and resource to run chemical analytic test in order to support the process and the production development of active ingredients as well as intermediates. F.I.S. is able to run most of the analytic test (either chemical or physical nature) internally as well as working in apposite environment to run stability test according to ICH regulation.

Traditional techniques

  • Thin-layer chromatography
  • Melting point determination
  • Titrations
  • Water content determination (Volumetric and coulometrico)

 

Separation sciences

  • HPLC and UPLC (multiple detectors e.g. UV, Fluorescence, CAD, Refractive index, Mass, ELSD, Polarimetric)
  • Gas chromatography (multiple detectors)
  • Head space Gas chromatography
  • Preparative HPLC
  • Ion chromatography
  • U -SFC, prep-SFC, GC-SFC

 

Spectroscopy

  • Infrared spectroscopy IR
  • Ultraviolet-Visible spectroscopy UV-Vis
  • Atomic absorption
  • ICP Inductively coupled plasma – OES
  • ICP Inductively coupled plasma – MS

 

Spectrometry

  • NMR
  • Mass Spectroscopy Single/Triple quadrupole, ToF
  • NIR
  • Powder colorimeter

 

Solid state characterization techniques

  • Electronic Microscope SEM
  • Particle size distribution determination (by laser light scattering e.g. Malvern 2000, Malvern 3000, Simpatec, Microtrac3500 or mechanical Alpine, Retsch)
  • XRPD X-Ray powder diffraction
  • Thermal analysis (DSC and TGA)

 

Other analytical techniques

  • Polarimetry
  • Particular matter test
  • Water Activity test
  • Appearance (including microscope, foreign matter test, colour determination, white index, etc.)
  • LAL test and all microbiological tests