Description

Alfuzosin Ep Impurity E is a high-purity reference standard used in the analytical characterization and quality control of the active pharmaceutical ingredient Alfuzosin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Alfuzosin Ep Impurity E in Alfuzosin HCl API and finished dosage forms.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for purer API.

Basic Information

Product Name	Alfuzosin Ep Impurity E
CAS No.	1026411-59-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alfuzosin Related Compound E; Alfuzosin Impurity E; Alfuzosin EP Impurity E; (2-{[4-[(2RS)-2-{[(2RS)-2-(2,2,2-Trifluoroethoxy)phenyl]amino}propyl]piperazin-1-yl}carbonyl)cyclopentyl)acetamide; UNII-9K0Q5H6F6P; 9K0Q5H6F6P; Alfuzosin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Alfuzosin Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, MS, NMR) to ensure compliance with pharmacopeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain 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)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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