Analytical Science Lab
Services
What We Do
We de-risk early-stage molecules with high precision analytics powered by state-of-the-art instrumentation: HPLC and UPLC with broad detection (PDA, FLR, ELSD, QDa, RI), spectrophotometers and well-plate readers for flexible assay formats, USP I, II, V and VI dissolutors for comprehensive release profiling, an accelerated high-pressure oxidation chamber for stress testing, and dedicated fraction collection for complex analytes.
Services
- Analytical method development and validation
- Release, stability and impurity profiling
- Quantitative assay of APIs, excipients and degradation products
End-to-end analytical development for assay, purity, and impurity profiling, ensuring robust in-process controls from day one.
Proven expertise in the characterization and troubleshooting of challenging molecules and intricate chemical matrices.
Modernizing legacy methods to meet current standards and ensuring analytical methods are “fit-for-purpose” before GMP validation.
Robust analytical data support for design space definition, utilizing statistical models to ensure method robustness and reliability, aligned with ICH Q14.
Method development aligned with ICH Q2(R2) principles to ensure a seamless future transfer to GMP environments.
Comprehensive stress testing and ICH Q1A stability studies across all global climatic zones for R&D purposes.
Specialized forced degradation protocols to identify oxidative susceptibility and optimize antioxidant selection and packaging strategies.
Accelerated Predictive Stability (APS): Utilizing high-stress, short-term data to accurately predict long-term stability and shelf-life, significantly shortening development timelines.
High-sensitivity quantification and kinetic profiling with spectrophotometer and well plate reader capabilities to accelerate assay development.
Robust method development and profiling in biorelevant media to characterize drug release, support specification setting, and strengthen regulatory submissions.
Let’s discuss your analytical development challenge
Contact
Dr. Jesús Afonso Urich