Our Advanced Analytical Technology
Method Development and Validation
We offer cutting-edge technology and specialized expertise to support method development and validation, ensuring the highest standards in drug development and production.
Impurity Isolation and Structure Elucidation
Method Validation and Verification
Accurate and reliable analytical methods are essential for consistent and reproducible results in pharmaceutical testing. Our method validation services follow strict ICH guidelines, ensuring that methods are fully validated for parameters like specificity, accuracy, precision, linearity, range, detection limit, quantitation limit, and robustness. We also offer method verification services to confirm that previously validated methods can be appropriately applied to specific products or materials, ensuring that each method performs as expected under actual testing conditions.
Studies in Support of Formulation Development
Our services extend beyond simple testing to provide comprehensive analytical support during formulation development. We perform targeted studies to evaluate the physical, chemical, and stability properties of drug formulations. This includes testing for solubility, particle size distribution, and excipient compatibility, helping to ensure that formulations are optimized for stability, bioavailability, and manufacturability. This data plays a crucial role in the development of robust formulations that perform consistently throughout clinical trials and manufacturing.
Chiral Separations
Chirality is a key consideration in pharmaceutical development, as the different enantiomers of a drug can have vastly different biological effects. Our chiral separation services utilize advanced chromatographic techniques, such as chiral HPLC and SFC (supercritical fluid chromatography), to separate and quantify enantiomers. This allows for the precise identification and control of the active enantiomer, ensuring that the drug formulation is safe and effective. Whether developing new drugs or ensuring compliance with regulatory requirements, our chiral separation expertise is essential for enantiomeric purity.
Charged Aerosol Detector (CAD) Method Development
The Charged Aerosol Detector (CAD) is a powerful analytical tool that provides universal detection for non-volatile compounds, offering superior sensitivity and dynamic range compared to traditional UV detectors. We specialize in the development of CAD methods for the quantification of compounds that are challenging to detect with other methods, including those without chromophores. Our CAD method development service includes optimization of detection conditions, ensuring precise and reliable detection across a wide range of applications, from small molecules to large biomolecules.
