Achieving consistent quality, stability and performance in pharmaceutical products depends on understanding and controlling solid‑state properties. As regulatory expectations evolve, robust characterization of crystalline materials and polymorphic forms remains essential throughout development and commercial manufacturing.

Our GMP‑compliant XRPD services provide reliable solid‑state analysis for raw materials, active pharmaceutical ingredients (APIs) and finished products, fully aligned with USP ⟨941⟩ and European Pharmacopoeia requirements. As a recognized standard technique, XRPD offers precise insight into crystalline structure to support regulatory submissions and lifecycle management.

To strengthen decision‑making in complex material assessments, we uniquely integrate GMP XRPD with polarized light microscopy (PLM). This combination enables comprehensive evaluation of pharmaceutical materials, including advanced testing approaches for talc. With validated methods and experienced scientific teams, we deliver dependable data that supports both routine quality control and compliance with global regulatory expectations.

XRPD expertise and applications

API characterization and solid-state analysis
Identify and characterize crystalline forms through polymorph screening, hydrate and solvate detection, and salt or co-crystal analysis. XRPD supports structural understanding, impurity assessment and unit cell indexing for development and patent applications.
Quality control and regulatory support
Support batch release and raw material identity testing using GMP-compliant XRPD methods aligned with pharmacopeial requirements. Testing verifies specification compliance and generates data suitable for regulatory submissions.

Why choose SGS?

We are the world’s leading testing, inspection and certification company, recognized as the global benchmark for quality and integrity. Combining specialized XRPD expertise with advanced instrumentation and global quality standards, we deliver independent analytical assurance that helps pharmaceutical organizations meet evolving regulatory expectations with confidence.