Bicalutamide impurity profiling is essential for quality control and regulatory compliance in oncology drug development. These impurities include process-related compounds, degradation products, and stereoisomeric variants. All materials are structurally characterized and qualified under ICH guidelines for use in pharmaceutical analysis and toxicological evaluation.
We offer a full suite of Bicalutamide EP impurities, including sulfoxide, sulfide, desfluoro, deshydroxy, and cyanobenzotrifluoride derivatives. These compounds are validated to meet European Pharmacopoeia specifications and are suitable for method development, forced degradation studies, and impurity quantification.
Our catalog includes Bicalutamide-related compounds such as R- and S-isomers, glucuronide conjugates, oxirane derivatives, and nitrosamine analogs. These compounds support impurity identification, genotoxicity screening, and analytical method validation. All materials are supplied with detailed analytical data and Certificates of Analysis.
Bicalutamide impurity reference standards are supplied with full structural characterization, validated analytical profiles, and EP/USP traceability. These standards are used in ANDA and DMF submissions, stability studies, and pharmaceutical research. All products meet global regulatory expectations and are re-tested at regular intervals to ensure ongoing compliance.
Address
Plot No. CP-135, Pimpri-Chinhwad MIDC, Pune-411019, Maharashtra, India.
© 2014-2024 SynThink Research Chemicals. All Rights Reserved.
Register to add the product to RFQ list
Already have an account? Log in here
Don’t have an account? Register here
