Quantification

Quantization methods are validated in order to quantify specific crystal forms or amorphous content in API mixtures and tablets (formulated compounds).

Depending on the physical-chemical API characteristics, one of the following techniques is chosen to obtain high accuracy, specificity and sensitivity:

• X-ray powder diffraction
• Thermal analysis (DSC)
• Spectroscopic analysis (FT-IR, FT-RAMAN)

The methods are built following GLP compliances and validated according to ICH guidelines.
In addition, for multiphase mixtures, such analysis reveals quantitative composition