Confarma

Testing solid form purity

Pharmaceutical product quality and reliability is assured by accurate and sensitive determination of form purity in the drug substance and / or drug product. Depending on the product, it may be necessary to quantify:

  • one crystalline form in another
  • crystalline fractions in an amorphous matrix
  • amorphous fractions in a crystalline substance

Selecting the optimal technique for such a purpose depends on the drug substance and the drug product. At Solvias, we are particularly experienced in quantifying low amorphous fractions of largely crystalline material, which is generally the most challenging task.

We choose the best technique for your substance to get the most sensitive levels of detection.

Examples of these include:

  • Powder X-ray diffraction (XRPD) - transmission and / or reflection
  • Raman spectroscopy
  • Differential Scanning Calorimetry (DSC)
  • Isothermal Microcalorimetry (IMC)
  • Solution Calorimetry (SolCal)
  • Dynamic Vapor Sorption (DVS)

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