Analytical Method Development & Validation
At LAXAI, we take pride in our commitment to developing the highest-quality drug substances and providing the necessary data for regulatory approval. To achieve this, we have equipped our analytical laboratories with a diverse array of cutting-edge technologies. Our laboratory is capable of performing precise drug substance assessments and characterizations to ensure that the compounds we develop meet the strict quality and purity standards set by regulatory agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
To ensure that our processes are efficient and cost-effective, we develop and validate all methods according to the standards required for each stage of development. Our analytical sciences team works closely with process chemists to develop robust methods that support the development process. We specialize in identifying and quantifying impurities in drug substances and tracing them back to their source to ensure the purity and safety of the final product.
At LAXAI, we conduct quality control analytical testing on active pharmaceutical ingredients, utilizing state-of-the-art, GMP-qualified equipment and facilities for all analytical work. Our team of experienced scientists and analysts are committed to delivering accurate and reliable results to our clients.
Infrastructure and Instrumentation:
- HPLC/ UPLC H with PDA, UV, ELSD and RI, CAD detectors
- LC-MS/MS/Trap & GC-MS/MS/Trap
- ICP – MS
- NMR (400 and 500 MHz)
- GC with Head-space – FID, TCD & ECD
- SFC – Analytical & Preparative
- Preparative HPLC
- DSC, DVS & TGA
- Volumetric and Coulometric KF
- UV-Vis spectrophotometer
- Auto titrator
- Ion Chromatography with Conductivity & Ampirometric detectors
- Malvern Mastersizer 3000 (PSD)