Structure Characterization and Impurity Analysis

Structural Characterization

Structural characterization is used to characterize whether the structure of the prepared intermediate product or drug substance is correct, thus laying a solid foundation for the next production of the product. This process is essential for understanding the composition and properties of drugs. The structural characterization techniques we use are mainly as follows:

• Nuclear Magnetic Resonance (NMR) Spectroscopy: NMR spectroscopy provides detailed information about the molecular structure, including the arrangement of atoms and functional groups within a molecule.
• Mass Spectrometry (MS): MS is used to determine the molecular weight and fragmentation patterns of compounds to aid in structural elucidation and identification.
• Infrared (IR) Spectroscopy: IR spectroscopy measures the absorption of infrared radiation by chemical bonds in a molecule, providing information about functional groups present in the compound.
• X-ray Crystallography: X-ray crystallography is a technique used to determine the three-dimensional structure of crystal materials, which provides detailed information at the atomic level.

Impurity Analysis

Impurity analysis involves the identification and quantification of impurities present in a drug substance or formulation. Impurities can arise from various sources, including the manufacturing process, degradation of the drug substance, or contamination during storage. It is essential to assess impurities to ensure they are within acceptable limits and do not pose risks to patient safety. The impurity analysis techniques we use are mainly as follows:

• High-Performance Liquid Chromatography (HPLC): HPLC is commonly used for separating and quantifying impurities in drug substances.
• Gas Chromatography (GC): GC is used for separating volatile compounds and is particularly useful for analyzing volatile impurities.
• Liquid Chromatography-Mass Spectrometry (LC-MS): LC-MS combines the separation capabilities of liquid chromatography with the detection capabilities of mass spectrometry, allowing for the identification and quantification of impurities with high sensitivity and specificity.
• Spectroscopic Techniques: According to the absorbance or emission characteristics of impurities, UV-visible spectroscopy, fluorescence spectroscopy and other spectroscopic methods can be used for detecting impurities.