With the constantly evolving technology, mass spectrometry (MS) coupled with high-performance liquid chromatography (HPLC) has become a standard practice used for drug development. LCMS is used to support small molecule drug development, such as impurity, degradant structure characterization, and qualification and quantification analysis.
LCMS for Drug Impurity Identification & Profiling
Impurity identification and profiling, crucial for ensuring the safety and efficacy of drug development and active pharmaceutical ingredients (APIs), are made possible with LCMS. Regulatory bodies have set stringent guidelines for identifying impurities at low levels, and LCMS analysis in Ahmedabad is recommended for small molecule drug development due to its reliability and efficiency. LCMS not only helps comply with these guidelines but also optimizes drug product development processes, providing a secure foundation for drug development.
LCMS in Small Molecule Drug Development
LCMS, with its combination of LC and MS, has become the preferred analytical method for its superior sensitivity and selectivity in pharmaceuticals. The efficiency of LCMS, achieved through continuous improvement in LC and MS, has made it prevalent in small molecule quantitation analysis. Aral Research provides LCMS service in Ahmedabad with High-efficiency UPHLC, allowing significant peak capacity improvements and shorter run times, ensuring both speed and accuracy in drug development.
The uniqueness of LCMS lies in its combined high resolving power of HPLC and superior mass analysis. It provides a solution to different structural characteristics in pharmaceutical research. This includes identifying trace levels of impurities and degradants in bulk drug substances, and most importantly, identifying metabolites in drug metabolism studies. LCMS plays a crucial role in identifying unknowns in synthetic reaction products. The most crucial aspect of pharmaceutical development is the identification of impurities in bulk drug substances. LCMS not only addresses concerns relating to relevant regulatory issues but also optimizes scale-up processes to maximize yield. The impurity content of 0.01% or above in API represents low picomoles of material in HPLC assay that need to be characterized. The use of LCMS can offer structural information on unknown impurities in production batches.
With the advancement in ionization techniques and instrumentation, liquid chromatography-mass spectrometry has become a powerful technology for the characterization of small molecules and proteins. At Aral Research, our HPLC testing labs in Ahmedabad emphasize high-throughput LCMS analysis, structural analysis of trace levels of impurities in drug substances, identification of metabolites and characterization for product improvements.
