Stability Screening

Overview

PolyCrystalLine can establish the stability of APIs over a wide range of temperature, pressure, stress and humidity variables.

PolyCrystalLine researchers can investigate conversion and interconversion of polymorph, amorphous, hydrate or solvate phases over wide temperature ranges.

Stability Screening Techniques

PolyCrystalLine assesses temperature, pressure, mechanical stress and humidity using a portfolio of advanced methods. These include:

Diffraction

X-Ray Powder Diffraction (XRPD) is usually the primary method to determine the form of a structure.

Spectroscopic

Fourier Transform Infrared (FTIR), solid-state nuclear magnetic resonance (NMR), and Raman spectroscopy can be used to observe light absorption, vibrational, rotational, and other low-frequency modes in the crystalline system.

Calorimetric

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

Thermogravimetric

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.

DVS

Dynamic Vapour Sorption (DVS) Intrinsic makes an important contribution in determining the stability of an API. The system rapidly measures uptake and loss of moisture by flowing a carrier gas at a specified relative humidity over a sample suspended within an ultra-sensitive digital microbalance.

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 Stability Screening for more 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