Description

Tamsulosin Ep Impurity D is a high-purity reference standard used in the pharmaceutical development and quality control of Tamsulosin hydrochloride, a widely prescribed α-blocker. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on regulatory compliance and impurity profiling. The CAS number for this compound is 1799280-05-9.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the analytical method development and validation of Tamsulosin HCl.
• Impurity Profiling and Control: Critical for monitoring and controlling the levels of this specific impurity during Active Pharmaceutical Ingredient (API) synthesis and formulation to meet ICH guidelines.
• Quality Assurance/Quality Control (QA/QC): Used in routine batch release testing in pharmaceutical QC laboratories to ensure product purity and regulatory compliance (e.g., USP, EP).
• Stability Studies: Employed as a marker to track impurity formation in drug substances and products under various stress and long-term storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Tamsulosin Ep Impurity D
CAS No.	1799280-05-9
Molecular Formula	C20H28N2O5S
Molecular Weight	408.51 g/mol
Synonyms	5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide; Tamsulosin Impurity D; Tamsulosin Related Compound D; Tamsulosin EP Impurity D; (R)-5-(2-((2-(2-Ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide; UNII-7V6P6C8Q8N
EINECS	Contact for details

Quality Control

Every batch of Tamsulosin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity, assay, and residual solvent analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
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.