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An active ingredient can turn up as a mix of several polymorphic forms. It is important to be able to detect the presence of another form, and, if needed, to quantify it to be sure to meet the regulations.
Besides, a solid form of an active ingredient can evolve towards an amorphous form during the different steps of the formulation process. Evaluation of amorphous content can be difficult to establish, though it remains essential.
Holodiag advises several analytical approaches (thermal or spectroscopic) according to the issues raised by the sample:
- pure API or formulation,
- low concentrations,
- weak response,
- concomitant phenomena during analysis, ...
in order to deliver reliable and reproducible results.
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