Quality Research & Analysis Services
Based on the expertise of our analytical research and development, QC and QA teams, we provide quality research and stability study services for active pharmaceutical ingredients (APIs), formulations, intermediates, and registered raw materials that meet regulatory submission requirements.
Our services include analytical method development/optimization, analytical method validation/transfer, physical and chemical property research, structure confirmation, reference standardization, product release testing, stability research, quality standard research, etc., which can meet various needs in the drug development process.
Our services include analytical method development/optimization, analytical method validation/transfer, physical and chemical property research, structure confirmation, reference standardization, product release testing, stability research, quality standard research, etc., which can meet various needs in the drug development process.
Analytical Method Development and Validation
- Provide method development reports suitable for IND/NDA Submission
- Systematic method screening system, combined with software evaluation and forced degradation experiments, to quickly establish stability-indicating related substances and content analysis methods
- Chiral impurities and purity analysis methods (chiral HPLC or SFC)
- Salt/acid/base ion analysis method (titration or ion chromatography)
- Software prediction and analytical method development (LC/MS/MS/GC/MS) for (potentially) genotoxic impurities
- Rapidly establish product-specific residual solvent control methods based on generic methods
- Moisture, XRPD, PSD, microbiological method development
- Comply with ICH Q3D elemental impurity analysis method
- Qualitative/quantitative NMR and other methods required for impurity structure analysis, confirmation and content calibration
- Full validation or transfer of methods in accordance with ICH and NMPA guidelines
Stability studies
- Forced degradation test and influencing factor test (light, acid, alkali, oxidation, high temperature, high humidity)
- Comply with ICH Q1 and NMPA guidelines (40°C/75%RH, 30°C/65%RH, 25°C/60%RH, 5°C)
- Generate plans and reports suitable for IND submission
- Support product stability studies at the commercialization stage
- Packaging material compatibility study
Standardization of reference materials and product release testing
- Physical and chemical properties research and testing
- Structural confirmation and full standardization of primary reference substances
- Preparation, separation, structure confirmation and standardization of impurities
- Product release testing
Quality Control Strategy
- Establishment of impurity control strategy
- Research and establishment of quality standards for IND/NDA submission
- Technical support in analytical method lifecycle management
- QRA, DoE and QbD study support
