Description

Tamsulosin Impurity F Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Tamsulosin HCl through precise impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control departments, and regulatory affairs teams focused on drug development and compliance. The product is supplied with comprehensive analytical data to support its use in method development and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Tamsulosin HCl.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in drug substances and products.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Tamsulosin HCl meets stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports synthetic chemistry research for impurity synthesis, isolation, and characterization studies.

Basic Information

Product Name	Tamsulosin Impurity F Hcl
CAS No.	1051368-80-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tamsulosin Related Compound F; Tamsulosin Hydrochloride Impurity F; Tamsulosin EP Impurity F; Tamsulosin USP Impurity F; (R)-5-[2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride Impurity; Benzenesulfonamide, 5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxy-, hydrochloride (1:1), impurity F
EINECS	Contact for details

Quality Control

Every batch of Tamsulosin Impurity F Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. Certificates of Analysis (COA) are provided, detailing comprehensive analytical results such as assay purity and impurity profiles. We support compliance with major pharmacopeial standards (USP, EP, ICH) for impurity reference materials.

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)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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