Analysis / Testing
Please contact us using this website inquiry form if you have any requests or questions concerning process analysis of drug substances or analysis and testing of drug substances and drug products.
Analysis / Testing
Analytical R&D Division of SPERA PHARMA develops the appropriate testing methods for process analysis of drug substances, drug substances and drug products according to their characteristics and the development stage, and proposes the quality control strategy, based on the technologies and experience acquired at leading Japanese pharmaceutical sciences.
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Process analysis of drug substances
- Development of all testing methods for such as raw materials, intermediates, residual metals and residual solvents et al. in manufacturing processes and their testing
- Support for in process analysis (structural estimation of impurities and risk assessment by thermal analysis)
- Development of highly-sensitive analytical methods for potential mutagenic impurities according to the ICH guideline M7
- Support for the control strategy of the regulatory starting materials
Analysis of drug substances and drug products
- Investigation of physical and chemical properties
- Development of testing methods for quality control and stability study of drug substances and various drug products (including oral and sterile formulations)
- Development of microbiological testing methods (microbial limit, endotoxin, sterility test)
- Method development for evaluation of functional drug product using various dissolution apparatus
- Method development for evaluation of crystalline polymorph in drug product
- Development of testing methods for excipients and packaging materials
- Compatibility evaluation with various components of injection product
- Structural elucidation of decomposition products and impurities
- Implementation of quality control tests and various stability studies
- Characterization for protein therapeutics; Glycan profiling, Peptide mapping and Intact mass analysis by LC/MS
- Isolation of microorganisms and rapid microbial identification by MALDI-TOF/MS
Support for applications (clinical trials and market authorization)
- Documentation of technical data (IND, CTD Module 3 etc. of NDA) necessary for clinical trials and marketing authorization.
- Data acquisition for application and support for inquiries from regulatory authorities
Main analytical instruments and equipment
- HPLC, UHPLC, GPC, KF, HIAC, LC/GC-MS, MALS, MS, NMR, IR, NIR, UV, Dynamic vapor sorption, Raman, Particle size, Powder X-ray, Thermal analysis (TG/DSC/DTA), TG/MS, XRD-DSC, Various apparatus for dissolution testing & disintegration testing, ICP-AES, ICP-MS, ELSD, CAD, Optical rotations, Various chambers for stability studies (long-term, accelerated, stress testing) etc.
Technologies and Achievements
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