Project Consulting

products-servicesPolyCrystalLine S.R.L.
May 30th 2014

 

Overview

PolyCrystalLine makes its extensive experience in solid-state systems and development of specific and flexible protocols for the study of crystalline forms available to clients on a consultancy basis.

These consultancy services can be adapted to meet specific client needs of the pharmaceutical industry and to solve any kind of issues related to active ingredients (APIs) or Investigational New Drug (IND) development.

Consulting Services

PolyCrystalLine consultants can help clients address complex issues arising in the preparation of substances complying with the Chemistry, Manufacturing & Controls regulated (regCMC) section of an IND. Consultancy services covert a number of key areas that determine success in drug development.

Characterization Research

For instance, a PolyCrystalLine consulting team can optimize characterization research to focus on an API crystalline form with the most desirable physical properties. This will assist the client to choose the optimal drug form.

If an undesirable polymorph is uncovered in either scale up and/or process transfer to other site(s), PolyCrystalLine experts will determine the root-cause and will propose appropriatecorrective action(s).

Design optimization

PolyCrystalLine Consulting can also help navigate through complex experimental design, parameter choosing, data interpretation and data correlation.

Stability management

Consulting services also include addressing potential changes that may occur during physical transformation processes, such as crystallization, drying, spray drying, milling, blending, granulation, tableting, and others.

Technical capabilities

PolyCrystalLine experts use comprehensive multi-technique approaches that can include a series of leading-edge analytical techniques. These include:

  • X-ray diffraction (PXRD, structure determination, etc.)
  • Spectroscopy (FTIR, Raman, NMR, etc.,)
  • Thermal analysis (DSC, TGA)
  • Microscopy (optical, electron)
  • Surface characterization (vapor sorption kinetics, specific surface area, etc.)

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:

  • X-ray powder diffraction 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 X-ray powder diffraction (XRPD) quantification methods for batch release.

Resources

Click on PolyCrystalLine Project Consulting for other information.
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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