Description

Bicalutamide Ep Impurity H 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 for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bicalutamide Ep Impurity H in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure API batches comply with stringent pharmacopeial limits (e.g., EP, USP, ICH Q3A/B) for specified impurities.
• Stability Studies: Acts as a critical marker to track impurity formation and degradation pathways in stability-indicating assays under various ICH storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate control over the impurity profile.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Bicalutamide Ep Impurity H
CAS No.	2512198-58-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bicalutamide Impurity H; Bicalutamide Related Compound H; Bicalutamide EP Impurity H; (R,S)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide Impurity; Bicalutamide Process Impurity; Casodex Impurity H; Bicalutamide Sulfone Impurity
EINECS	Contact for details

Quality Control

Our Bicalutamide Ep Impurity H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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