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Preformulation Characterization

"A Supportive Antecedent Approach for Formulation Development"

Preformulation refers to the collective studies directed at defining the chemical and physical properties of a new drug candidate. The purpose of the preformulation process is to guide and optimize the preclinical formulation development of a suitable dosage form for Phase 0, Phase I, and beyond. A team engaged to perform pre-formulation studies having core expertise with end-to-end profiling of molecules on following tests:

  • Polymorph Screening & Selection
  • Salt Form Selection
  • pH Solubility & Stability
  • Solid-state & Solution-state Stability
  • pKa & Partition Coefficient Determination
  • Excipient Compatibility
  • Micromeritics property
  • Structure characterization (XRD, FTIR, DSC, NMR,SEM,TEM)
  • Extractable and leachables studies
  • Analytical method development
  • Impurity identification
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