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