Analytical R&D

  • The research center is supported by 22,000 Sft of analytical development block
  • A wide range of chromatography and spectroscopic techniques (HPLC, RRLC, GC, FT-IR, UV etc) to meet the requirements of different types of compounds
  • Analytical Method development with experimental design and product monograph
  • Analytical Method Validation with protocol and report
  • Stability-indicating assay and/or related substances methods for drug substance
  • Degradation pathway ascertainment with report for regulatory submission
  • Other specific methods, like residual solvents, potential genotoxic impurity, enatiomeric separation, counter-ion estimation, solubility profile etc
  • Structure elucidation for impurity/degradation product by LC/MS/MS and NMR spectroscopy
  • Reference standard characterization with CoA or full characterization report
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Indian Patents Filed
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