Pantoprazole EP Impurity B (Pantoprazole USP Related Compound B, Pantoprazole Sulfide)(CAS: 102625-64-9)

Pantoprazole EP Impurity B (CAS: 102625-64-9) is a sulfide derivative of pantoprazole, a proton pump inhibitor used in pharmaceuticals. It has the molecular formula C16H18N4O2S2 and is characterized by its white to off-white crystalline appearance. This compound is commonly identified during drug quality control processes to ensure purity and compliance with regulatory standards.

Pantoprazole EP Impurity B (CAS: 102625-64-9) is primarily used in pharmaceutical research and quality control to detect and quantify impurities in pantoprazole formulations. It may also serve as a degradation product or byproduct in drug manufacturing. Its presence is critical for assessing the safety and efficacy of pharmaceutical products, particularly in adherence to USP and EP specifications.

Pantoprazole EP Impurity B (CAS: 102625-64-9) is generally considered safe when handled according to standard laboratory protocols, but it requires caution. Limited toxicity data suggests it is less hazardous than the parent compound, but proper protective measures such as gloves and ventilation should be used. Safety standards under ICH guidelines emphasize monitoring its levels in drug products to ensure they remain within acceptable thresholds.

Pantoprazole EP Impurity B (CAS: 102625-64-9) should be stored in a sealed, light-resistant container at controlled room temperature (15-30°C) or refrigerated conditions (2-8°C) to maintain stability. It is sensitive to moisture and light, so desiccation and protection from humidity are essential. Storage should comply with chemical safety regulations to prevent degradation or contamination.