Analytical Development
Bora provides customized analytical solutions for small molecules. Depending on product development phases, and global relevant regulatory guidance (ICH, FDA, USP, EP, JP etc.), Bora designs customized analytical solutions utilizing state of the art equipment, and performs under GMP environment specifically targeting your need. Bora is also equipped with Empower 3 software to ensure data integrity.
Explore
Bora provides service for stability indicating methods, and preliminary evaluation of method feasibility/ suitability.
Develop
Bora will perform studies as needed including but not limited to the followings to build an analytical test method with satisfied reliability and robustness.
- Sample Solubility/ Stability
- Scouting Gradient and Optimized Chromatographic Conditions
- Peak Purity Examination
- Maximum Detect-ability
- Selective Forced Degradation
- Robustness Evaluation
Optimize
Bora performs method qualification (validation/verification/transfer/ equivalency study) with elements evaluated as appropriate, and provides high quality documentations that meets regulatory expectations.
- Linearity
- Accuracy
- Precision (Repeatability/ Reproducibility)
- Specificity
- Qualification Limit (LOQ)
- Detection Limit (LOD)
- Robustness
- Solution Stability
- Robustness
- Forced Degradation Study
Bora helps examine and improve performance of existing test procedures for less troubleshooting and higher throughput.
Instrumentation Capability
- Chromatography: HPLC-PDA/UV/RI/FL, UPLC-UV/PDA/MS, IC-Conductivity, GC/FID/TCD
- Spectroscopy: UV, IR, Polarimeter, - Titration: Karl-Fisher titration system, Auto Titration System
- Malvern 2000 Particle Analyzer , Disintegration Testers, Dissolution Testers, TOC, TGA, Sieve Shaker (agitation mode: vibration, Air jet, ultrasonic), viscosity meter, Capillary Electrophoresis System