SGS Expands GMP-Compliant Solid State Analysis Services at it Lincolnshire, IL, US Facility

SGS Life Science Services has invested in X-Ray Powder Diffraction (XRPD) capabilities at its Lincolnshire, IL, laboratory for solid state analysis. The service, which has been fully qualified and validated, can now be offered to clients wishing to study crystallinity and polymorphism under cGMP conditions.

With this technique, the laboratory adds a comprehensive polymorph analysis, screening and determination service, complementing existing capabilities in Differential Scanning Calorimetry (DSC) and Thermo-Gravimetric Analysis (TGA). XRPD can also be used to identify crystalline materials, pursuant to USP <941> testing, as well as quantitative phase analysis and assessment of the degree of crystallinity of solids. The non-destructive nature of XRPD makes it suitable for systematic pre-formulation studies and for testing drug–excipient compatibility.

Installed and fully operational, the XRPD instrument is equipped with a very sensitive LynxeyeE detector which allows methods to be developed and optimized quickly without compromising data quality. Analysis under cGMP conditions is possible as the diffractogram is 21 CFR compliant.

“This investment is in response to growing client demand for extended solid-state characterization testing,” commented Mark Rogers, Senior VP, Life Science Services, SGS North America. “Adding XRPD to our global portfolio of services broadens the company’s expertize and widens our offering for both existing and potential new clients. The fact that we can offer this new service with full cGMP compliance is a key differentiator.”