Amoxicillin EP Impurity C

Amoxicillin EP Impurity C, also known as 2-Hydroxyethylthioethyl amoxicillin, is an organic compound that is used in the pharmaceutical industry as an impurity reference standard for the analysis of amoxicillin drug substances and products. The impurity is derived from the synthesis of amoxicillin, which is a β-lactam antibiotic used to treat bacterial infections. The presence of Amoxicillin EP Impurity C in amoxicillin drug substances and products can affect their quality and efficacy, and therefore, its quantification is important for ensuring the safety and effectiveness of amoxicillin-based medications. Chemically, Amoxicillin EP Impurity C is a white to off-white crystalline powder with a molecular formula of C11H20N2O5S and a molecular weight of 288.35 g/mol. It is soluble in water and ethanol, and its melting point ranges from 98°C to 102°C. The impurity is structurally related to amoxicillin, containing a β-lactam ring and an amide group. The usage of Amoxicillin EP Impurity C involves its quantification in amoxicillin drug substances and products using various analytical techniques such as high-performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS). The impurity reference standard is used to establish the limit for its acceptable levels in amoxicillin-based medications, which is typically set at 0.2% or lower. In conclusion, Amoxicillin EP Impurity C is an important reference standard used in the pharmaceutical industry for the analysis of amoxicillin drug substances and products. Its quantification is crucial for ensuring the safety and effectiveness of amoxicillin-based medications, and its chemical information and properties are important for its identification and characterization.