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
- Cation & Anion 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)
- High Resolution Mass Spectroscopy (HRMS)
- 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