Description

Tamsulosin Ep Impurity A is a specified impurity and reference standard used in the quality control of Tamsulosin Hydrochloride, an active pharmaceutical ingredient (API) for treating benign prostatic hyperplasia. This compound is critical for pharmaceutical manufacturers to ensure product purity, safety, and compliance with stringent pharmacopeial guidelines such as the European Pharmacopoeia (EP). It is primarily required by analytical laboratories, quality assurance departments, and R&D facilities within the pharmaceutical industry for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Tamsulosin-related impurities in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Used in routine quality control laboratories to monitor impurity profiles and ensure Tamsulosin API and formulations meet EP, USP, or other specified purity criteria.
• Stability Studies: Employed to track the formation of degradation impurities in Tamsulosin products under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate control strategy and product safety.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Tamsulosin, supporting formulation improvement and shelf-life extension.

Basic Information

Product Name	Tamsulosin Ep Impurity A
CAS No.	918867-88-6
Molecular Formula	C20H28N2O5S
Molecular Weight	408.51 g/mol
Synonyms	5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide; Tamsulosin Impurity A; Tamsulosin Related Compound A; Tamsulosin EP Impurity A; (R)-5-(2-((2-(2-Ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide; Tamsulosin Sulfonamide Impurity; UNII-2S4Y4C9H8P
EINECS	Contact for details

Quality Control

Our Tamsulosin Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identification (IR, NMR), and residual solvent analysis. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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