List of studies that can be performed at our laboratory for polymorphism:
  • Morphology
  • Identification of polymorph
  • Evaluation of polymorph for patent
  • Quantification of polymorph
  • Indexing and unit-cell determination
  • Percentage crystallinity
  • Equilibrium solubility
  • Intrinsic dissolution profile of the polymorph
Panalytical-Malvern Empyrean XRD (Reflection/Transmission configuration) Salient Features:
  • Polymorphic interpretation and evaluation based on literature or patent data
  • Qualitative identification of polymorph in drug substance and drug product
  • Quantitative determination of undesired polymorph in the desired polymorph of drug substance and drug product with higher sensitivity and lower detection
  • Phase Identification in a polymorphic mixture
  • Analytical method development and validation of qualitative and quantitative determination of desired and undesired polymorph in drug substance and drug product
  • Analytical method validation of qualitative and quantitative determination of desired and undesired polymorph in drug substance and drug product as per ICH guideline Q2(R1)
  • % Crystallinity determination in drug substance and drug product
  • Rietveld analysis using polymorphic analysis
  • Indexing and unit-cell determination
  • Drug product analysis using transmission geometry