Comprehensive analytical method development services
Analytical offerings are specifically customized to our clients’ needs based on development phase and dosage form. We are able to test to current USP, Ph.Eur., JP and other compendia.
Expert-led analytical research and development team
Bora’s cohesive and interdisciplinary analytical team are comprised of highly skilled analytical chemists, drug development specialists, quality control specialists, and project managers.
Our Analytical Development team develops custom analytical solutions and have a proven track record in small molecule method development. Our experienced team has improved and resolved challenges with numerous analytical test methods for simple to complex modified release products.
Analytical method development capabilities
Stability Methods
We develop stability indicating methods, can complete a preliminary evaluation of method feasibility/suitability and perform studies to build reliable and robust analytical test methods in line with your phase appropriate development needs.
- Sample Solubility/Stability
- Scout Gradient and Optimize Chromatographic Conditions
- Peak Purity Examination
- Maximum Detectability
- Selective Forced Degradation
- Robustness Evaluation
Method Development
We can perform method evaluation and qualification to ensure that a method is suitable for the intended purpose in addition to method validation, verification, transfer, or equivalency studies.
- Linearity
- Accuracy
- Precision (Repeatability/Reproducibility)
- Specificity
- Qualification Limit (LOQ)
- Detection Limit (LOD)
- Ruggedness/Robustness
- Method/Solution stability
- Range
State-of-the-art Instrumentation
Chromatography:
- Utilizing Empower 3 and Feature Release 5 software
- HPLC-PDA/UV/RI/FL
- UPLC-UV/PDA/MS
- IC-Conductivity
- GC/FID/TCD
Spectroscopy:
- UV
- IR
- Polarimeter
- Titration: Karl-Fisher and Auto Titration System
Other equipment:
- Malvern 2000, 3000 and Helo Sympatec Particle Analyzers for wet and dry dispersions
- Disintegration Testers
- Dissolution
- TOC, TGA analyzers
- Sieve Shakers
- Viscosity Meters
- Capillary Electrophoresis Systems
