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Analytical Chemistry Services
Jubilant Biosys offers its customers wide range of analytical chemistry services most promising results with rapid/short time lines. 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.
- Structure elucidation by LC-HRMS, NMR, FT-IR & UV-Visible.
- X-Nuclei NMR (1H, 2H, 7Li, 11B, 13C, 15N, 19F, 23Na, 27Al, 29Si, 31P, 119Sn, 195K)
- 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)
- Crystallization studies
- Polymorph screening
- Polymorph characterization
Physicochemical Study
- Melting point
- Solubility
- pKa
- Log P determination
- Optical rotation
- Elemental analysis
- Solid state analysis (DSC, TGA and XRPD)
- Polarimetry
- KF Titration
- IR Spectroscopy
Impurity Profiling
- Isolation of impurity
- Structure elucidation
- Impurity synthesis
Analytical Method Development/Validation for CMC
- HPLC-UV/PDA/ELSD/Chiral methods for in-process, intermediates and NCE API
- Impurities/Assay by HPLC/UPLC – as per ICH Q3
- Elemental Impurities/ (ICP-OES/MS) – as per ICH Q3D
- Forced degradation study
- ICH compliant stability studies – as per ICH Q1A
- Residual solvents analysis by GC as per ICH guidelines
- GMP
Infrastructure (Analytical Instruments) Details & Capabilities
- HPLC/UPLC with PDA, UV, ELSD and CAD detectors
- LC-MS, LC-MS/MS, HS-GC-MS & HRMS
- ICP-MS
- NMR (400 MHz)
- SFC-MS Analytical & Preparative
- Preparative HPLC
- FT-IR
- Volumetric and Coulometric KF
- UV-Vis spectrophotometer
- Auto titrator
- Polarimeter
- pXRD
- Microscopy
