Description

Silodosin is a highly selective α-1A adrenergic receptor antagonist used primarily in urological therapeutics. This compound is critical for the formulation of pharmaceutical products designed to manage the symptoms of benign prostatic hyperplasia (BPH). It is essential for manufacturers in the global pharmaceutical and fine chemical industries seeking a reliable, high-purity active pharmaceutical ingredient (API). Our supply of Silodosin CAS NO 160970-64-9 ensures consistent quality and compliance with stringent regulatory standards.

Application

• Pharmaceutical API: Primary active ingredient in medications for the treatment of benign prostatic hyperplasia (BPH).
• Generic Drug Manufacturing: Sourcing for the production of generic silodosin capsules and tablets.
• Clinical Research: Used as a reference standard or raw material in preclinical and clinical studies.
• Formulation Development: Serves as a key component in the R&D of new dosage forms and drug delivery systems.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for finished dose production.
• Regulatory Submissions: Provides the necessary quality documentation (DMF, CEP) to support regulatory filings worldwide.

Basic Information

Product Name	Silodosin
CAS No.	160970-64-9
Molecular Formula	C25H32F3N3O4
Molecular Weight	495.54 g/mol
Synonyms	KMD-3213; (1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indol-7-yl) acetate; Silodosin hydrate; UR-150; UR-150K; UR-150K1; UR-150K2
EINECS	Contact for details

Quality Control

Our Silodosin is manufactured under strict quality management systems in compliance with cGMP guidelines. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to ensure it meets pharmacopeial standards. Certificates of Analysis (COA) detailing purity, related substances, residual solvents, and other critical parameters are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Meets ICH Q3C guidelines

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