Description

Silodosin n-Oxide is a key pharmaceutical intermediate and metabolite of the active pharmaceutical ingredient Silodosin. This compound is of significant importance in the research, development, and quality control processes for urological medications. It is primarily utilized by pharmaceutical manufacturers and analytical laboratories for method development, impurity profiling, and reference standard applications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Silodosin and its related substances.
• Impurity Profiling: Critical for identifying and quantifying the n-Oxide degradant in Silodosin drug substance and finished dosage forms to ensure product safety and stability.
• Metabolite Studies: Employed in pharmacokinetic and pharmacodynamic research to study the metabolism of Silodosin in biological systems.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS, for regulatory compliance.
• Process Chemistry Research: Used in route scouting and process optimization for the synthesis of Silodosin, helping to understand and control oxidation pathways.
• Quality Control (QC) Testing: An essential standard in QC laboratories to monitor the purity and stability of Silodosin batches against specified limits.

Basic Information

Product Name	Silodosin n-Oxide
CAS No.	2361272-05-9
Molecular Formula	C25H32F3N3O4
Molecular Weight	495.54 g/mol
Synonyms	Silodosin N-Oxide; Silodosin Impurity N-Oxide; Silodosin Related Compound N-Oxide; 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide 1-Oxide; KMD-3213 n-Oxide; Urief Impurity N-Oxide; Rapaflo Impurity N-Oxide
EINECS	Contact for details

Quality Control

Our Silodosin n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
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.