Description

Bicalutamide Ep Impurity F is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Bicalutamide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis and validation of Bicalutamide.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Bicalutamide Ep Impurity F in API batches.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish system suitability and validate impurity profiling procedures.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure Bicalutamide API meets pharmacopeial specifications (e.g., EP, USP, ICH guidelines).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Research & Development (R&D): Used in process chemistry to understand and control impurity formation during the synthesis of Bicalutamide.

Basic Information

Product Name	Bicalutamide Ep Impurity F
CAS No.	1080647-26-2
Molecular Formula	C18H14F4N2O4S
Molecular Weight	430.38 g/mol
Synonyms	Bicalutamide Impurity F; Bicalutamide Related Compound F; (2RS)-3-[4-Cyano-3-(trifluoromethyl)phenyl]-N-[4-fluoro-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide S-Oxide; Bicalutamide Sulfoxide; Casodex Impurity F; Bicalutamide EP Impurity F; Bicalutamide Sulfoxide Impurity
EINECS	Contact for details

Quality Control

Our Bicalutamide Ep Impurity F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and confirmed against pharmacopeial standards where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identification, and impurity profile as determined by advanced techniques like HPLC and NMR.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.