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.
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Dubai Investments Park 1,
The Green Community,
P.O. Box: 34924,
Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001
Fax: +971 4 885 4004