Description

Tamsulosin Impurity 1 is a specified impurity of the active pharmaceutical ingredient Tamsulosin Hydrochloride, used in the treatment of benign prostatic hyperplasia. This compound is critical for pharmaceutical manufacturers and analytical laboratories for method development, quality control, and regulatory compliance. It is essential for ensuring the purity, safety, and efficacy of the final drug product through rigorous impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tamsulosin Hydrochloride drug substance and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research & Development: Facilitates synthetic route optimization and process chemistry studies by identifying and quantifying process-related impurities.

Basic Information

Product Name	Tamsulosin Impurity 1
CAS No.	116091-64-6
Molecular Formula	C20H28N2O5S
Molecular Weight	408.51 g/mol
Synonyms	5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide; Tamsulosin Related Compound A; Tamsulosin EP Impurity A; Tamsulosin USP Impurity A; (R)-5-[2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide; AMR 69 Impurity; AMR-69 Impurity
EINECS	Contact for details

Quality Control

Our Tamsulosin Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized and controlled against pharmacopeial standards where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH, USP, and EP guidelines for impurities in new drug substances.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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