Application Note PHARM008
Introduction
Polymorphs of active pharmaceutical ingredients (APIs) undergo phase transitions when temperature and humidity change. And it also, which an affect their solubility and stability. XRD and DSC are widely used in the development stage of APIs. However, in single measurements it is difficult to correlate the structural and thermal changes due to misalignment of conditions, which may lead to misjudgment. Simultaneous XRD-DSC measurement improves the accuracy of polymorphism evaluation by observing structural and thermal changes at the same time.
Crystalline phase analysis
| Analysis: | Active pharmaceutical ingredients |
| Use: | Pre-formulation (API) |
| Analyzed materials: | Carbamazepine (CBZ) |
| Analysis software: | SmartLab Studio II |
Figure 1: XRD-DSC measurements of carbamazepine
(under high humidity atmosphere)
Conclusion
Figure 1 shows the results of XRD-DSC measurements of carbamazepine while heated at high humidity (8.6 kPa). The XRD-DSC measurement can accurately capture the polymorphic transition associated with changes in temperature and humidity. And this method will contribute to improving the reliability of stability evaluation in formulation design.
