Thermal Screening

Overview

Once X-Ray Powder Diffraction (XRPD) and other tests have established the basic crystalline structure of substance, thermal screening techniques may be needed to gain additional information on the new form including melting point, thermal transitions and thermodynamic stability.

While fast crystallization methods commonly produce meta stable forms by trapping the unstable state during the crystallization process, slow crystallization tends to result in thermodynamically stable forms.

Additional characterization of new forms including solvent content using thermogravimetric, differential scanning and spectroscopic methods can also help determine if a new powder pattern represents a new form or a mixture of forms.

PolyCrystalLine studies the thermal behaviour of pharmaceutical compounds by means of a broad range of techniques. These include:

Variable temperature XRPD
Variable temperature X-Ray Powder Diffraction provides a powerful tool to probe reaction kinetics in crystalline pharmaceuticals since it permits simultaneous quantification of multiple solid phases.

DSC Calorimetric testing
Differential scanning calorimetry can be used to observe fusion and crystallization events in the structure as well as transition temperatures, oxidation and other chemical reactions.

Thermogravimetric tests
Thermogravimetric analysis (TGA) uses heat to force reactions and physical changes in structures. TGA provides quantitative measurement of mass change in materials associated with transition and thermal degradation and can determine endotherms, exotherms, and weight loss on heating, cooling, and more.

Evolved gas analysis
Thermogravimetric Analysis combined with Infrared spectroscopy (TGA/FTIR) can build up a picture of evolved gases produced from the TGA. Evolved gas analysis (EGA) studies the gases evolved from a heated sample that undergoes decomposition or desorption. EGA can yields information on composition (mass numbers of elements and molecules) along with bonding conditions.

Quality & Certification

PolyCrystalLine s.r.l. has been inspected and approved by the Italian Health Department for compliance with Good Laboratory Practice (cGLP). This certification includes:

• XRPD analysis (quantitative/qualitative)
• Particle size distribution analysis
• DSC Analysis
• TG Analysis
• FT-IR (quantitative/qualitative)
• Karl Fischer
• Melting Point
• Dissolution Test
• U(H)PLC
• FT-Raman
• DVS Intrinsic
• PSD
• EASYwater

PolyCrystalLine is also completing Good Manufacturing Practice (cGMP) certification in application, to allow development and validation of XRPD quantification methods for batch release.

Resources

Click on PolyCrystalLine Thermal Screening for other information.
Click on PolyCrystalLine to contact the company directly.

Supplier Information
Supplier: PolyCrystalLine S.R.L.
Address: VIA F.S Fabri, 127/1 40059 – Medicina (Bologna), Italy
Tel: +39 051 6970791
Fax: +39 051 851 847
Website: www.polycrystalline.it