Amorphous Content Determination
Crystalline substances are generally less than 100% crystalline. The crystallization
process itself may already produce some amorphous solids, and subsequent
processing steps (such as melt quenching, freezing and spray drying, grinding, wet
granulation and so on) may destroy the original crystal structure and cause chaos.
Amorphous impurities have very different physicochemical properties than when they
are in a crystalline state. It makes the solid form of the drug no longer well defined, its
storage stability will be reduced, and the aggregation behavior of the powder may
change. Therefore, the detection, quantification, characterization and management of
amorphous components play a central role in ensuring process control during the
development and manufacturing stages. The commonly used methods of amorphous
content determinations include X-ray powder diffraction, differential scanning
calorimetry, dynamic vapor sorption and so on.
Fig.1 Quantitation of the amorphous content with thermal methods.
CD Formulation laboratories can test products of any scale, and we can provide
comprehensive amorphous content determination for APIs according to related
standards. Our scientists will help you to make a decision for operational and
procedural conditions that can ensure the physical and chemical stability and
