PRECEDO Chemistry Services
Custom Synthesis. Accelerated Discovery.
Analytical Chemistry
PRECEDO’s Analytical Chemistry services provide robust, regulatory-aligned support across the drug development lifecycle, ensuring data integrity, method reliability, and seamless progression toward GMP and regulatory submission.
Method Development
- HPLC/UPLC methods for purity and impurity profiling of starting materials, intermediates, and APIs
- Assay development, impurity and degradation product analysis
- Residual solvents, moisture content, and elemental impurities
- Chiral method development for enantiomeric separation
- Genotoxic impurity analysis
- Dissolution testing and cleaning validation methods
Method Validation
- Validation in accordance with ICH, FDA, USP, and NMPA guidelines
- Specificity, accuracy, precision, linearity, and robustness assessments
- Forced degradation and stress studies to establish stability-indicating methods
Method Transfer
- Transfer and verification of analytical methods from client labs, external partners, or compendial sources
- Readiness for GMP testing and regulatory submission
- Cross-site reproducibility and consistency assurance
Documentation
- Comprehensive method development and validation protocols
- Detailed validation reports and finalized analytical methods
- Structured review and approval processes aligned with regulatory expectations
Analytical Chemistry Capabilities
Reprogramming Cells, Empowering Medicine
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