Analytical


Analytical

Our Analytical Methods Laboratory provides analytical support to our R&D laboratories through documentation and validation of test results as per ICH guidelines

Capabilities
  • Development of analytical methods to test starting materials, intermediates APIs and finished dosages
  • Validation of analytical test methods as per ICH guidelines
  • Characterization and standardization of reference standards
  • Characterization of Proteins and Peptides
  • Impurity profiling, polymorph testing and stability studies of APIs
  • Pre-formulation and dissolution studies
  • Analytical test methods transfer
  • Support to the Regulatory Department by provision of data, documents and reports for regulatory submissions for domestic and international product registrations (EU-DMFs, US-DMFs, ANDAs and dossiers)
Infrastructure
  • HPLCs
  • LC/MS/MS
  • GCs
  • GC-MS
  • Ion Chromatography
  • NMR
  • UV-Vis and FTIR Spectrophotometers
  • X-ray crystallographic capabilities for polymorphism studies
  • X-ray Diffractometer
  • Autotitrators
  • CHNS and O analyser
  • Amino Acid analyzer
  • DSC
  • TGA
  • HPTLC
  • CZE
  • Automated dissolution testers





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