Crystallinity Determination

Most active pharmaceutical ingredients are produced in crystalline form to ensure their chemical stability during transportation, packaging and storage. Crystallinity plays an important role in drug dissolution rate, physical and chemical stability, physical properties of tablet compaction and drug bioavailability. Even a small amount of amorphous phase in a crystalline sample may significantly change its physical and chemical properties. Therefore, the crystallinity determination of the active pharmaceutical ingredient is very important to ensure the quality of the final product.

Proposed mechanism of spherical agglomerationFig.1 Proposed mechanism of spherical agglomeration (Kovačič B, et al. 2012)

CD Formulation can provide you with crystallinity determination services of active pharmaceutical ingredients, and our scientists will help you to make a decision for operational and procedural conditions that can ensure the physical and chemical stability and pharmacological activity of the product to minimize potential formulation and stability issues.

Our Methods for Crystallinity Determination

  • Differential scanning calorimetry (DSC)
  • FT-Raman spectrometry
  • X-ray powder diffraction (XRPD)
  • Near infrared spectroscopy (NIRS)

Deliverable

  • Data analysis
  • Provide full study report

Our Advantages

Crystallinity Determination

How to Contact Us?

If you have a requirement about crystallinity determination services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

  1. Byard S J, Jackson S L, Smail A, et al. Studies on the Crystallinity of a Pharmaceutical Development Drug Substance[J]. Journal of Pharmaceutical Sciences, 2005, 94(6): 1321-1335.
  2. Gao D, Rytting J H. Use of Solution Calorimetry to Determine the Extent of Crystallinity of Drugs and Excipients[J]. International Journal of Pharmaceutics, 1997, 151(2): 183-192.

Online Inquiry

Please note: Our products and services can only be used for research purposes. Do not use in diagnostic or therapeutic procedures!
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