Chiral drugs have enantiomers with the same chemical formula but different spatial structural formulas, and enantiomers with chiral centers are usually divided into S-type and R-type. The proportion of chiral drugs in generic drugs is gradually increasing, and the pharmacological activity of chiral drugs directly depends on the chiral characteristics of drugs. Different enantiomers of chiral drugs may have differences in drug efficacy, metabolism, and toxicology, which can roughly be divided into the following situations.
- Drug's biological activity is produced exclusively or predominantly by one of the enantiomers
- The two enantiomers have completely opposite biological activities
- One enantiomer has severe toxic side effects
- The biological activities of the two enantiomers are different, but the combination of the two enantiomers is advantageous.
- Both enantiomers exhibit the same biological activity
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Quality control of chiral drugs is crucial for the efficacy of drugs, which has attracted the attention of regulatory agencies and pharmaceutical companies in recent years. Chiral analysis of drugs is usually performed early in drug development. Our company provides reliable and efficient development and validation of chiral drug analysis methods, as well as sample testing services for global pharmaceutical manufacturers.
Analysis methods are directly related to the accuracy of analytical results. Therefore, the selection of the appropriate purity analysis method is the primary issue in the study of chiral drug quality. Our company's analytical technology for chiral drugs primarily includes chromatographic technology and an optical rotation method.
Optical rotation is widely used in the development and production of optically active drugs. Optical rotation is a method to measure or check the purity of drugs by using the optical rotation phenomenon that occurs when plane-polarized light passes through a liquid or solution containing chiral molecules. It can also be used to determine the content of chiral compounds. Our company strictly selects the light source and other measuring conditions, so that the measured specific curl value is moderate, which can sensitively reflect the optical characteristics of the drug.
In general, it is not appropriate to only use the optical rotation method as the quality control index of optical purity. Especially in the formulation process and research stage of generic drugs, it is necessary to strictly control the content of chiral impurities. Thus, the optical rotation method needs to be combined with other analytical methods with stronger stereospecificity and higher sensitivity to better control the optical purity of products.
Considering the specificity and sensitivity of the method, our company adopts HPLC (High-performance Liquid Chromatography), GC (Gas Chromatography) and UPCC (Ultra-Performance Convergence Chromatography) technology to separate and quantify chiral compounds.
- Validation of analysis methods
For the validation of analytical methods for chiral drugs, stereospecificity is the focus of the investigation. Stereospecificity refers to a method that accurately determines the properties of the tested substance in the presence of other chiral impurities that may coexist. By virtue of the perfect experimental equipment platform and rich experience in the development of chiral compounds, our company can quickly develop analytical methods with high sensitivity and excellent separation.
Chiral drug analysis plays a critical role in the research and development of generic drugs, which is one of the key steps in determining drug properties, effects, and stability. Based on the relevant requirements of the national pharmacopeia and the actual situation of the customer's chiral drug project, our company provides efficient and high-quality method development and validation services that meet regulatory requirements.
