Overcoming Impurity Challenges, Ensuring Drug Safety！
In the drug development and manufacturing process, the identification, analysis, and control of impurities are critical steps to ensure drug safety, efficacy, and stability. Trace levels of uncontrolled impurities can pose a serious threat to drug safety and are a top priority for scrutiny by global regulatory authorities. As a trusted partner to the global pharmaceutical industry, Protheragen Impurity provides clients with comprehensive impurity research services spanning the entire drug lifecycle.
Our Platform
Protheragen Impurity’s robust service capabilities are rooted in our world-class, multi-technology platforms.
Synthetic Chemistry Platform
- Capabilities: Complex organic synthesis, metal catalysis, asymmetric synthesis, enzymatic catalysis, photochemistry, high-/low-temperature reactions, high-pressure hydrogenation.
- Equipment: Multi-functional synthesis reactors, high-pressure reactors, continuous flow chemistry systems.
- Focus: Custom synthesis of high-difficulty impurities, genotoxic impurities (GTIs), isotope-labeled impurities, and molecules with multiple chiral centers.
Separation & Purification Platform
- Capabilities: Chiral and achiral separation, trace impurity enrichment, purification of highly polar/non-polar compounds.
- Equipment: Preparative high-performance liquid chromatography (Prep-HPLC): Multiple systems equipped with various detectors (UV, ELSD, CAD), supporting normal-phase and reverse-phase modes.
- Focus: Solving high-difficulty separation challenges to deliver high-purity impurity reference standards.
Analytical Characterization Platform
- Capabilities: Structural elucidation and confirmation, high-sensitivity quantitative/qualitative analysis, impurity analysis, method development and validation, elemental analysis, water content/residual solvent determination.
- Equipment: Mass spectrometry, nuclear magnetic resonance (NMR), high-performance liquid chromatography (HPLC), gas chromatography (GC), circular dichroism (CD), X-ray diffractometer (XRD), etc.
- Focus: Provides a complete data package for structure confirmation and physicochemical characterization.