Analytical Capabilities
Phase-Appropriate Approach to Develop User-Friendly Methods
Our analytical capabilities include services supporting process development, cGMP/AP| manufacturing and stability studies, and other stand-alone analytical projects.
Process Development
- Analytical Impurity Elucidation
- Analytical Method Development
- Reference Standard & Stability Studies
cGMP/API Production
- Release Methods for RSM, Intermediates and API
- Stability Indicating Method Validation
- Reference Standard Certification
- Specifications
- Release Testing
Stability Studies
- ICH Stability Conditions
- Photostability Study
- Forced Degradation
Part 11 Compliance Data logger for real time monitoring - ≥ 50 on-going studies
Analytical Products
- Impurity studies for API & DP
- Method development for challenging separations
- Method development for pGTl
- Investigation of Analytical Result Discrepancy as a Third Party
- Method keeper
- Release Testing
Analytical Services
J-STAR Research provides analytical development and quality control (QC) expertise at all stages of Drug Substance (DS) and Drug Product (DP) development. Our team of expert scientists, equipped with tailored workflows and advanced instrumentation, delivers actionable insights that enhance product quality, reduce development timelines, and ensure regulatory compliance.
Our services include:
- Fast-paced and cost-efficient method development
- Comprehensive impurity profiling, including impurity identification and quantitation at all stages
- Excipient compatibility studies
- Method validation and verification
- Release testing for raw materials, registered starting materials, intermediates, APIs, and DPs
- Genotoxic impurity analysis
- ICH stability studies
- Forced degradation and degradation pathway understanding
- Analytical method troubleshooting
Capabilities at a Glance
- HPLC and GC method development for challenging separations, including chiral separations
- Extensive method development and testing using LC/MS, LC/CAD, GC/FID, GC/MS, NMR, TGA, KF, DSC, FT-IR, Polarimetry, and ICP-MS
- Method transfer/validation
- Reference standard certification
- Separation and characterization of impurities and degradants
- cGMP release testing for raw materials, intermediates, and APIs
- Stability studies: stability indicating method development and stability sample testing
- Genotoxic impurity method development and testing
Solid State / Particle Size / Form Characterization
Our dedicated group uses state-of-the-art instruments for comprehensive characterization, contributing to our crystallization R&D capabilities.
Analytical Equipment
| Instruments Qualified / Calibrated for GMP Use |
|---|
| Agilent HPLC & UPLC systems / UV & MS |
| Thermo Dionex UPLC / CAD & UV |
| Agilent GC/FID with headspace and direct injection |
| Agilent GC/MS with direct injection |
| Nicolet Avatar FT-IR Spectrometer |
| OptiMelt Automated Melting Point |
| Metrohm KF Coulometer with direct sample introduction and sample oven |
| Mettler Toledo balance/Micro-balance |
| Stability Chambers/Freezers as being set up at the following conditions: -20 °C • 5°C • 25°C/60% RH • 30°C/65% RH • 40°C/75% RH |
| ICP-MS for elemental impurities |
| IC for counter ion determination |
| XRPD for crystal form determination |
| PSD for particle size determination |
| DSC/TGA for thermo analysis |
| Instruments for R&D |
|---|
| Agilent GC-MS systems |
| Agilent GC-FID systems |
| UPLC/High Resolution MS (Thermo Orbitrap Elite Velos/Waters Accurity) |
| Varian Inova NMR Systems 300 and 400 MHz Bruker NMR Systems 400 & 500 MHz |
QC Data Integrity: Part 11 Compliance
Agilent OpenLab
- CDS (Chromatographic Data System): Full Instrument Control, Data Acquisition and Interpretation
- ECM (Enterprise Content Manager): Centralized Secure Scientific Content Management
Chromeleon
- Thermo HPLC and UPLC Systems
Vaisala
- Real-Time Temperature and Humidity Monitoring