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第一行主标题 请输入要描述的内容进行内容补充请输入 - Polymorphy identification in ultra-low content formulations 第一行主标题 请输入要描述的内容进行内容补充请输入 - Non-destructive reverse engineering of advanced formulations 第一行主标题 请输入要描述的内容进行内容补充请输入 - Crystallization process and product online monitoring |
Identification of Unknown Excipients Reference formulations typically list the types of excipients they contain. However, critical excipients that are not disclosed in these lists and exist in very low quantities can directly impact the formulation process and dissolution mechanisms of the drug product. Failing to accurately analyze whether the originator includes these critical low-level excipients can significantly increase the workload of the generic drug development process. Conversely, effectively and accurately identifying these excipients, along with understanding their functionalities, can greatly streamline the development of generic drugs, making the process more efficient and effective. Application Case of Raman Spectroscopy in the Analysis of Low-Content Components Our company utilizes Raman spectroscopy in the analysis of low-content components. different substances. For instance, the API content is approximately 3% (magenta), excipient 1 (green), excipient 2 (red), and so on. Figure 1. Raman Imaging Distribution Map of the Formulation Figure 2. Comparison of Mapping Spectrum with Component Spectrum in the Formulation Figure 2 shows the Mapping spectrum of each component in the formulation, as well as spectra of individual components. By directly comparing the spectra, the signal peaks of main components 1-5 can be observed, confirming their presence. However, for components with potentially very low concentrations, their characteristic peaks may not be clearly visible. Therefore, there are two possibilities: either the spectrum of these components is masked or these components may not exist. Figure 3. Principal Component Data Model of Mapping Spectrum Figure 4. Comparison of PC6 Data Model with Spectrum of Component X Summary: Through Raman spectroscopy, we are not only able to detect formulations using Mapping images and gather extensive data for analysis, but also combine point detection methods to obtain the required data more accurately and swiftly, achieving qualitative or quantitative analysis. Additionally, we possesses a vast pharmaceutical excipient database with comprehensive information. We have established an intelligent data retrieval system to enhance data mining and analysis capabilities. By searching and comparing information within the database, we can rapidly and accurately identify unknown excipients, significantly accelerating the drug development process. |