Crystal Pharmatech Officially Launches GMP-Compliant QC Laboratory for Solid-State Characterization

Suzhou, China – June 2026 – Crystal Pharmatech, a science-driven CRO/CDMO specializing in solid-state research, formulation development, and manufacturing of small molecule, announced the official launch of its new GMP-compliant Quality Control (QC) Laboratory dedicated to solid-state characterization.

Located in Crystal Pharmatech's headquarters in Suzhou Industrial Park, the facility has been designed and operates in accordance with current GMP requirements, further strengthening the company's quality management system and analytical service capabilities.

The newly established laboratory marks a significant milestone in Crystal Pharmatech's ongoing commitment to providing high-quality, regulatory-compliant analytical support for pharmaceutical development and manufacturing programs.

Advanced Analytical Capabilities for GMP-Regulated Testing

The QC laboratory has been purpose-built to meet GMP standards, ensuring controlled operations, reliable data generation, and full traceability throughout the testing process.

Key instrumentation includes:

• X-Ray Powder Diffraction (XRPD) – Bruker D8 Advance, supporting comprehensive polymorph identification and characterization studies.

• Particle Size Distribution (PSD) Analysis – Mastersizer platform for particle size and particle distribution characterization.

• High-Precision Weighing Systems – Mettler Toledo analytical balances with microgram-level sensitivity to ensure accurate sample preparation and measurement.

• Controlled Storage Systems – Pharmaceutical-grade refrigeration and temperature-controlled storage units to maintain sample integrity under regulated conditions.

Together, these capabilities provide a robust analytical platform for GMP-compliant polymorph and particle size testing.

（Left：Mastersizer  / Right：Bruker D8 Advance）

Supporting Global Pharmaceutical Development

Backed by a robust quality management system and advanced analytical infrastructure, Crystal Pharmatech's GMP QC laboratory provides clients with reliable polymorph and particle size testing services that meet regulatory expectations across global markets.

The new facility complements the company's existing research quality system and CNAS-accredited capabilities, enabling flexible support for clients operating under varying quality and regulatory frameworks. By integrating research and GMP-compliant testing capabilities, Crystal Pharmatech is well-positioned to support both innovative and generic drug development programs from early-stage development through commercialization.

Original link for the article:

https://www.crystalpharmatech.com.cn/news_view.aspx?t=15&contentid=244