Identification of the polymorphic form of an Active Pharmaceutical Ingredient (API) is of critical importance when dealing with API’s prone to changing crystal structure during the life cycle of the pharmaceutical product. 

The Food and Drug Administration (FDA) requires that the crystal form of the API in any pharmaceutical product is known and that changes during manufacturing be understood and documented. Exova offers services for polymorph identification, as well as method development and validation for products in the form of creams, suspension, and solid dosages.

 Our techniques for polymorphism and crystal identification include:

  • X-Ray Powder Diffraction (XRPD) spectroscopy
  • Raman spectroscopy
  • Differential Scanning Calorimetry (DSC), enthalpy of melting
  • Fourier Transform Infrared (Micro-FTIR) Spectroscopy
  • Scanning Electron Microscopy (SEM) and Light Microscopy (LM) for morphology
  • Image analysis software.

When the API is present at low levels, or there is crystallographic interference from the excipients, our team of chemists can develop methods to isolate the API from your product without changing the crystal structure.

  • Contact Us

    Whatever your query, we'll pass it on to our experts and respond within a very short space of time.
    More details
Pharmaceutical teting facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111

Fax: +1 905 823 1446

Email: americas@exova.com

Click to view dynamic map

9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562 948 2225

Fax: +1 562 948 5850

Email: americas@exova.com

Capabilities
Click to view dynamic map

Plot 598-221, Dubai Investments Park 1, The Green Community, P.O. Box: 34924,
Dubai

Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001

Fax: +971 4 885 4004

Email: middle.east@exova.com

Click to view dynamic map