Product Number: P034008A
English Name: Dexpanthenol EP Impurity B(Sodium salt)
English Alias: sodium (R)-2,4-dihydroxy-3,3-dimethylbutanoate
CAS Number: 60979-68-2
Molecular Formula: C₆H₁₁O₄·Na
Molecular Weight: 170.13
Product Advantages: Dexpanthenol EP Impurity B(Sodium salt) features high purity and a well-defined structure, which has been strictly identified by multiple spectroscopic techniques (such as nuclear magnetic resonance and mass spectrometry). It exhibits stable chemical properties and consistent performance under various environmental conditions. As a reference substance, it can accurately be used for the impurity detection of Dexpanthenol-related products, ensuring accurate, reliable, and highly reproducible detection results. It provides a solid guarantee for pharmaceutical quality research and quality control, facilitating quality monitoring in drug research, development, and production processes.
Application Fields:
Quality Control: As an impurity reference standard, it is used to establish and validate the detection methods for impurities in Dexpanthenol bulk drugs and formulations, ensuring that the sensitivity and specificity of the detection methods meet the requirements of pharmacopoeia standards such as the European Pharmacopoeia (EP), effectively guaranteeing drug quality.
Process Optimization: During the production of Dexpanthenol, by monitoring the content of this impurity and analyzing the stages and causes of its generation, it helps to optimize the synthesis process, reduce impurity formation, and improve product quality and production efficiency.
Stability Studies: In drug stability tests, it analyzes the changes of this impurity under different storage conditions (such as temperature, humidity, light), providing key data support for determining the shelf life and storage conditions of drugs, and ensuring the quality stability of drugs during storage and transportation.
Background Description: Dexpanthenol is commonly used in pharmaceuticals, cosmetics, and other fields. In medicine, it can promote skin wound healing and improve hair texture. In the process of its research, development, production, and quality control, impurity research is a crucial aspect to ensure drug safety and effectiveness. The presence of impurities may affect the efficacy of Dexpanthenol and even pose potential risks. As a related impurity of Dexpanthenol, in-depth research on Dexpanthenol EP Impurity B(Sodium salt) helps to comprehensively evaluate the quality of Dexpanthenol drugs, improve the drug quality evaluation system, and ensure the safety and effectiveness of related products in various application scenarios.
Research Status: Currently, research on Dexpanthenol EP Impurity B(Sodium salt) continues to progress. In terms of detection technology, advanced detection methods such as Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS) and ion chromatography are constantly being explored to achieve precise detection of trace impurities. In the study of impurity generation mechanisms, the formation causes and influencing factors are deeply analyzed by simulating drug synthesis reactions and storage environments, providing a theoretical basis for optimizing the production process and controlling impurities from the source. In addition, research on the impact of this impurity on the efficacy and safety of Dexpanthenol is also gradually being carried out, aiming to further clarify its role in product quality evaluation and provide more comprehensive evidence for industry standard setting and product quality improvement.
China
