Polymorph Purity and Amorphous Content

Accurate and sensitive determination of polymorphic purity in both drug substance and drug product, as well as the identification of the amorphous content in the drug substance, assures product quality and reliability. Based on the substance specifics, the best technique is selected to obtain the most sensitive levels of detection. Our portfolio includes, for example:

• Powder X-ray diffraction
• Raman spectroscopy
• Differential scanning calorimetry
• Highly sensitive microcalorimetry
• Dynamic vapor sorption

Whether for identity testing, limit testing or quantification, methods are developed with a view to future validation and routine testing under cGMP.