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Analytical Chemistry

The analytical service portfolio of Sai Ganga Panakeia includes entire range of analytical services supporting different phase of Discovery, formulation and CMC Support.
Discovery (NCEs, API, Proteins, Peptides)

  • Analytical Method Development
  • Chemical and Chiral purity
  • Mass and UV-LC purification
  • Impurities : forced degradation studies including identification and purification by LCMS/MS
  • Analytical reference standard isolation and characterization
  • Lab-scale natural product purification capabilities
  • Physiochemical Characterization
  • Isolation of related substances by various methods including HPLC, etc.
  • Residual solvents
  • Particle Size
  • Identification tests (FTIR, NMR, LCMS)
  • X-ray Powder diffraction
  • Validation of Analytical Procedures (Actives and related substances etc.)
  • Isolation of compounds from natural extracts.

CMC Support

The analytical service portfolio of Sai Ganga Panakeia includes entire range of analytical services supporting different phase of Discovery, formulation and CMC Support.
Discovery (NCEs, API, Proteins, Peptides)

  • Analytical method Development Report with:
     Preliminary degradation data
     Physical & chemical characteristics
  • Standard Test Procedures for: 
    Raw material, Intermediates and Finished product
    In-process controls
  • Primary Reference Standard Qualification and Characterization (Purity, Assay, ROI,KF, Residual Solvents, etc)
  • Impurity profiling for Key starting materials and final product.
  • COA Preparation
  • Stability studies (ICH conditions)
  • Analytical Method transfer
  • Solid state characterization

Pre Formulations

  • Discovery formulation development
  • Solubility studies
  • Assay and Homogeneity
  • Stability studies
  • Dissolution