Drug Product


Asymchem Drug Product Formulation Lab

Analytical Techniques and Tools to Move Development Forward

Asymchem understands that early phase work focuses on learning as much as possible about a drug compound. Our experience across numerous chemical classes and multiple dosage forms, and our ability to develop analytical methods to assess chemical identity, purity, compatibility, and stability, makes us a natural choice for this preformulation work. Our in-depth knowledge of the compound from preformulation guides us in designing manufacturing processes that control the product’s quality attributes, ensuring the product meets its Quality Target Product Profile (QTTP).

We offer a full spectrum of analytical techniques and tools, from XRPD to proton and carbon NMR, from mass spectrometry to hygroscopicity testing. In addition, our broad experience with many diverse classes of drug substances and multiple drug product dosage forms, has increased our expertise around chemical compatibilities, degradation pathways, stability, and the tools to investigate these areas.

Preformulation Services

  • Polymorph screening
  • Crystallization optimization
  • Physical characterization—XRPD, SEM, PSD
  • Purity/impurity testing
  • Stability testing
  • Excipient compatibility testing
  • Structure characterization –LC-MS, full range of proton and carbon NMR techniques, single crystal x-ray analysis, chiral purity