Analytical


Analytical Research and Development

USV has a state of the art analytical research and development laboratory which supports development of Small molecules, Peptide molecules, Drug substances and Drug products meeting global regulatory requirements.

Capabilities
  • Analytical method development for Drug substance (Raw materials, Intermediates and Peptides) and Drug Products (i.e. Solid Oral, Injectable and Ophthalmic Dosage Forms) considering aQbD approach
  • Structural characterization studies
  • Deformulation studies and Reverse engineering
  • Impurity profiling
  • Polymorph identification studies
  • In-Vitro Dissolution studies
  • Elemental analysis (CHNS)
  • Elemental impurities analysis
  • Nitrosamine analysis
  • Genotoxic impurities analysis
  • Extractable and Leachable study
  • Development stability studies
  • Characterization of Reference Standards and Impurity standards
  • Characterization of Proteins and Peptides
  • Peptide mapping and amino acid sequencing
  • Amino acid analysis
Infrastructure
  • Separation techniques
  • High Performance Liquid Chromatography (HPLC) with multiple detectors
  • Ultra Performance Liquid Chromatography (UPLC) with multiple detectors
  • Gas Chromatography
  • Liquid Chromatograph with Mass Spectroscopy (LC-MS/MS)
  • Gas Chromatography with Mass Spectroscopy (GC-MS/MS)
  • Analytical Ultra Centrifugation
  • Ion Chromatography
  • Characterization techniques
  • Particle size analyser
  • Dynamic Light Scattering
  • Dynamic Vapor Sorption
  • Nuclear Magnetic Resonance Spectroscopy
  • Inductively coupled Plasma Mass Spectrometer
  • UV-Vis and FTIR Spectrophotometers
  • X-ray Powder diffraction
  • CHNS and O analyzer
  • Differential Scanning Calorimetry
  • Thermal Gravimetric Analysis
  • Spectrofluorophotometer
  • Wet analysis
  • Auto Titrators
  • Osmometer
  • Automated Dissolution Testers
  • KF Coulometer
  • Potentiometer





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