Analytical Chemistry

Jubilant Biosys offers its customers wide range of analytical chemistry services with most promising results in short timelines. The services include quantitative and qualitative analysis, structural confirmation, chemical characterization and purifications (achiral and chiral) are performed as needed using advanced technologies.

The analytical team provides support to discovery and process chemistry groups as an integrated service or a stand-alone option for our customers. Our unique approach allows us to identify and evaluate the chemical in our analytical testing laboratories rapidly and effectively communicate the resulting data to help our customers understand the product’s chemistry.

Purification

  • Chiral/achiral purifications (milligrams to multi Kg).
  • Isolation of impurities, metabolites, natural products and degradation products.

Structure Elucidation

  • Structure elucidation of new chemical entities (NCE’s), impurities, degradation products, metabolites and natural products.
  • X-Nuclei NMR (1H, 2H, 7Li, 11B, 13C, 15N, 19F, 23Na, 27Al, 29Si, 31P, 119Sn, 195K)
  • Structure elucidation by LC-HRMS, NMR, FT-IR & UV-Visible.
  • NMR special experiments (2D-NOESY, COSY, HMBC, EDHSQC, Selective Gradient 1D-NOESY / ROESY, TOCSY, 2D-ROESY, DOSY, H2BC, etc).

Solid State Characterization

  • Solid state analysis (DSC, TGA and XRPD)
  • Polymorph screening
  • Crystallization studies
  • Polymorph characterization

Physicochemical Study

  • Melting point
  • pKa
  • Optical rotation
  • Solid state analysis (DSC, TGA and XRPD)
  • KF Titration
  • Solubility
  • Log P determination
  • Elemental analysis
  • Polarimetry
  • IR Spectroscopy

Impurity Profiling

  • Isolation of impurity
  • Impurity synthesis
  • Structure elucidation

Analytical Method Development/Validation for CMC

  • HPLC-UV/PDA/ELSD/Chiral methods for in-process, intermediates and NCE API.
  • Elemental Impurities/ (ICP-OES/MS) – as per ICH Q3D.
  • ICH compliant stability studies – as per ICH Q1A.
  • GMP
  • Impurities/Assay by HPLC/UPLC – as per ICH Q3.
  • Forced degradation study.
  • Residual solvents analysis by GC as per ICH guidelines.

Infrastructure (Analytical Instruments) Details & Capabilities

  • HPLC/UPLC with PDA, UV, ELSD and CAD detectors
  • ICP-MS
  • SFC-MS Analytical & Preparative
  • FT-IR
  • UV-Vis spectrophotometer
  • Polarimeter
  • Microscopy
  • LC-MS, LC-MS/MS, HS-GC-MS & HRMS
  • NMR (400 MHz)
  • Preparative HPLC
  • Volumetric and Coulometric KF
  • Auto titrator
  • pXRD