Description

Silodosin is a highly selective α-1A adrenergic receptor antagonist, a key active pharmaceutical ingredient (API) used in the treatment of benign prostatic hyperplasia (BPH). Its targeted mechanism of action provides effective relief from lower urinary tract symptoms with a favorable side effect profile. This compound is essential for pharmaceutical manufacturers developing and producing finished dosage forms, primarily capsules or tablets, for the global urology market. Silodosin CAS NO 160970-54-7 is supplied under stringent quality control to ensure batch-to-batch consistency and regulatory compliance.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for treating Benign Prostatic Hyperplasia (BPH).
• Finished Dosage Formulation: Direct incorporation into solid oral dosage forms such as capsules and immediate-release tablets.
• Clinical Research: Serves as a reference standard and raw material in preclinical and clinical studies for urological conditions.
• Generic Drug Manufacturing: Critical for companies producing generic versions of branded Silodosin medications.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for pharmaceutical production.
• Regulatory Submissions: Used to generate stability and characterization data for drug master files (DMF) and regulatory dossiers (e.g., ANDA, NDA).

Basic Information

Product Name	Silodosin
CAS No.	160970-54-7
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-indole-7-carboxamide); Silodosin Hydrochloride (salt form); Urief; Rapafio; Silodyx; 8-[3-(4-Methoxyphenyl)propyl]-1-phenethyl-1,3,8-triazaspiro[4.5]decan-4-one (related structure)
EINECS	Contact for details

Quality Control

Our Silodosin is manufactured and tested to meet the highest pharmacopeial standards, including ICH Q7 guidelines for active pharmaceutical ingredients. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant regulatory requirements for markets worldwide, supporting our clients' needs for GMP-grade materials in drug production.

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 low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Heavy Metals	NMT 20 ppm

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