Analytical research and development involve pre formulation, stability, and degradation studies of APIs and other drugs, as well as preparation of technical archives for registration in China and other countries. The analysis and development team provides specific services to various departments of the research center.
Uther provides method development and validation services for various analytical techniques. Adhering to GLP and cGMP regulations enables companies to support all stages of drug development based on customer specific protocols, internal SOPs, and FDA and ICH guidelines. The analysis and development laboratory is equipped with HPLC with PDA/UV detector, GC-FID with headspace sampler, GC-HS-MS, UPLC, UPLC-MS, ion chromatograph, atomic absorption spectrophotometer, FTIR, UV visible spectrophotometer, Total organic carbon analyzer, nuclear magnetic resonance and XRD.
- Evaluate the manufacturing factory and provide fast response according to factory requirements
- According to Complete Document
- Perform instrument calibration according to cGLP.
- Environmental monitoring and analysis.
- Provide microbiological support and analysis
- Impurity analysis, separation, and characterization.
- Verify the analysis method according to regulatory guidelines (ICH and USFDA).
- To evaluate precision, accuracy, specificity, linearity, detection range limit, quantification limit, and durability
- Develop complete specifications for raw materials, APIs, finished products, intermediates, and excipients
- Including internal testing to strictly control pharmacopoeia materials and products.
- Conduct stability studies on APIs and formulations according to ICH guidelines.
- Research on API prefabrication agents.
- Structural analysis and characterization of impurities were carried out through UV, infrared, chromatography, DSC, elemental analysis, mass spectrometry, and nuclear magnetic resonance.
- Use differential scanning calorimetry and XRD to characterize polycrystalline compounds.
- Analysis of active ingredients and key raw materials.
- Provide fast and accurate analysis support for the API formula department.
- Develop analytical methods (instrumental analysis and wet analysis).