Bicalutamide EP Impurity D(CAS: 654-70-6)

Bicalutamide EP Impurity D (CAS: 654-70-6) is a pharmaceutical impurity associated with the drug Bicalutamide, a nonsteroidal anti-androgen used in prostate cancer treatment. It is a structural variant or degradation product of the parent compound, typically identified during quality control processes. The chemical formula is C20H24N2O, and it exhibits properties similar to Bicalutamide, including solubility in organic solvents. Its presence is monitored to ensure drug purity and safety.

Bicalutamide EP Impurity D (CAS: 654-70-6) is primarily used in pharmaceutical research and quality control to identify and quantify impurities in Bicalutamide formulations. It serves as a reference standard for analytical testing and regulatory compliance. Additionally, it may be employed in drug development to study impurity profiles and their impact on therapeutic efficacy and safety. Its applications are limited to non-therapeutic purposes in laboratories and manufacturing.

Bicalutamide EP Impurity D (CAS: 654-70-6) is not intended for therapeutic use and its safety profile is less established compared to the parent drug. However, it is generally considered safe in trace amounts when handled properly. Precautions include wearing protective gloves and ensuring adequate ventilation during handling. Safety standards for pharmaceutical impurities, such as ICH Q3A, emphasize minimizing exposure and adhering to controlled environments to prevent health risks.

Bicalutamide EP Impurity D (CAS: 654-70-6) should be stored in a cool, dry place (25°C), protected from light, and kept in an airtight container. It is recommended to maintain low humidity levels to ensure stability and prevent degradation. Storage in a desiccator is ideal to avoid moisture absorption. Always follow safety guidelines for handling chemical impurities to maintain product integrity and user safety.