Quality Control Center GMP Analytical Capabilities and Facilities

The QC team performs various tests and analyses, including physical and chemical tests, to ensure the safety and efficacy of high-quality active pharmaceutical ingredients (A.P.I.). -

  • Assay, identification, and related substance content by HPLC-UPLC-LC/MS, ion chromatography, gas chromatography (GC), GC equipped with head space sampler, and GC-MS techniques.
  • Enantiomeric purity by HPLC and polarimetry
  • UV spectroscopy and IR spectroscopy
  • Colorbox
  • NMR (400 MHz) for GMP release
  • Water content by KF,pH, density, and potentiometric assay determination (wet chemistry)
  • Physical properties and solid-state characterization by melting point, thermogravimetric analysis (TGA), and differential scanning calorimetry (DSC)
  • Cleaning, validation, and verification
  • A fully validated GMP Laboratory Management System (LEMS) for data acquisition, recording, evaluation, and reporting, tailored to pharmaceutical QC needs
  • All ICH-like stability studies on active pharmaceutical ingredients for worldwide registration are guaranteed by different climatic conditions.
  • The QC center facility is set up to handle, sample, and analyze HPAPIs and cytotoxic product