Description

Tamsulosin Hydrochloride Ep Impurity-C is a high-purity reference standard specifically used for the analytical control of Tamsulosin Hydrochloride, a widely prescribed α-blocker medication. This impurity is critical for pharmaceutical manufacturers and quality control laboratories to ensure drug safety, efficacy, and compliance with stringent pharmacopeial monographs. It is an essential component for method development, validation, and routine testing in the production of Tamsulosin Hydrochloride active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, UPLC, and other chromatographic assays in quality control laboratories.
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating methods for Tamsulosin Hydrochloride API and formulations.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiling and identification data.
• Stability Studies: Used to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability testing of drug products.
• Pharmacopeial Testing: Enables compliance testing as per European Pharmacopoeia (EP), United States Pharmacopeia (USP), and other international pharmacopeia requirements for impurity limits.
• Research & Development: Serves as a key material in R&D for studying the degradation pathways and chemistry of Tamsulosin Hydrochloride.

Basic Information

Product Name	Tamsulosin Hydrochloride Ep Impurity-C
CAS No.	2244986-82-9
Molecular Formula	C20H28N2O5S • HCl
Molecular Weight	444.98 g/mol
Synonyms	Tamsulosin EP Impurity C; Tamsulosin Hydrochloride Impurity C; Tamsulosin Related Compound C; (R)-5-[2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide Hydrochloride; Tamsulosin HCl Impurity C; Tamsulosin Impurity C (Hydrochloride); AMS-559 HCl Impurity C
EINECS	Contact for details

Quality Control

Every batch of Tamsulosin Hydrochloride Ep Impurity-C 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, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

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

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