Solid State Characterization and Polymorph Quantification

The physical properties of any pharmaceutical solid material can impact the bulk properties of material, formulation performance, ease of processing, stability and its final appearance. Solid state characterization is essential to understanding the physical properties and ensuring that the pharmaceutical product has an optimal physical form.

To support your R&D and regulatory filings, VIMTA offers physical characterization services including polymorph characterization, thermal analysis, spectroscopic analysis and particle size determination. Our offerings include:

  • Identification and characterization of polymorph
  • Screening
  • Identification (Qualitative)
  • Estimations (Quantitative)
  • Melting Point/Range for drug substances
  • Exotherm and Endotherm Determinations
  • Decomposition temperature
  • Glass Transition
  • Thermal Analysis as per USP for Plastics i.e. Polymers (HDPE, LDPE, Homopolymer Polypropylene and Co-Polymer Polypropylene)
  • Loss on Drying in DS & DP
  • Residue on Ignition (NCEs)
  • Hydrate Confirmation in DS
  • Carbonate Content Estimation in DS
  • Bound Moisture estimation
  • Monitoring the stability of polymorph
  • Method development, validation, method verification for polymorph identification and quantification
  • Particle size distribution (morphology) through wet and dry methods