Amorphous Screening

Overview

Some amorphous APIs (including disordered crystalline and microcrystalline solids) will offer bioavailability advantages through enhanced solubility and high relative free energies. However, amorphous substances offer few advantages where their form exists in a stable free energy or poorly ordered crystalline state.

PolyCrystalLine can conduct micro amorphous screens to quantify and analyse the crystalline form of amorphous substances, using a series of advances techniques.

Screening for Amorphous Materials

PolyCrystalLine experts can prepare amorphous forms on the micro scale using a variety of methodsbased on 0.1mg to 5mg samples. These include:

• Spray drying
• Quench cooling of the melt

Samples can also be analyzed by x-ray powder diffraction (XRPD), where appropriate.

PolyCrystalLine is also able to evaluate the conditions of conversion into the crystalline phase. The laboratory can investigate the stability of an amorphous phase using solid-statenuclear magnetic resonance (NMR) and Raman spectroscopy, observing vibrational, rotational, and other low-frequency modes in the crystalline system.

Quality & Certification

PolyCrystalLine s.r.l. hasbeen 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 Amorphous 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