Solid Form Troubleshooting

Solid Form Analysis to overcome unexpected challenges in Pharmaceutical Development

Unexpected solid-state issues can arise at any stage of pharmaceutical development, manufacturing, and storage. These can directly impact on drug substance and drug product stability, bioavailability, manufacturability, and regulatory compliance. Our team specializes in solid form troubleshooting using state-of-the-art solid-state analysis techniques. This allows us to quickly identify and resolve these challenges efficiently, ensuring a smooth path from discovery to production.

XRPD to perform solid-state analysis to troubleshoot solid form issues during manufacturing and storage of drug substance and drug products.
Solid-state troubleshooting in drug substance manufacturing, pharmaceutical development and drug product manufacturing
  • Identification of transitions from one solid form to another during formulation, manufacturing and storage
  • Detection and Quantification of one crystalline form in another crystalline form
  • Determination of the limit of detection of crystalline forms in complex matrixes
  • Determination of an amorphous content in a crystalline matrix or vice-versa
  • Evaluation of coating thickness in tablets
  • Batch-to-batch comparison and batch troubleshooting: identification of developing and manufacturing issues giving raise to different properties between batches
  • Comparability studies: generic versus innovator
  • Infringing form detection: crystalline impurity identification in drug substance and drug product, related to pharmaceutical development and Hatch-Waxman litigations
  • Visible and sub-visible particle detection, isolation and analysis to identify their composition and origin