Description

Silodosin Glucuronide is a key pharmacologically active metabolite of the selective α1A-adrenoceptor antagonist Silodosin. This compound is of significant importance in the pharmaceutical industry for research, development, and quality control processes. It serves as a critical reference standard and intermediate for analytical method validation, pharmacokinetic studies, and impurity profiling. Professionals in pharmaceutical R&D, analytical laboratories, and contract manufacturing organizations require this high-purity compound to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative and qualitative analysis of Silodosin and its metabolites in biological matrices and finished drug products.
• Metabolite Studies: Essential for conducting in-vitro and in-vivo ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand the pharmacokinetic profile of Silodosin.
• Impurity Profiling: Used to identify, quantify, and monitor this specific glucuronide conjugate as a potential impurity or degradation product in Silodosin active pharmaceutical ingredient (API) and formulations.
• Bioanalytical Method Development: Critical for developing and validating sensitive HPLC, LC-MS, or LC-MS/MS methods for therapeutic drug monitoring and clinical trial sample analysis.
• Pharmacological Research: Employed in research to further elucidate the activity, potency, and receptor binding characteristics of Silodosin's major metabolites.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for a significant human metabolite, as required by ICH M3(R2) and M10 guidelines.

Basic Information

Item	Details
Product Name	Silodosin Glucuronide
CAS No.	879396-70-0
Molecular Formula	C29H38N4O9
Molecular Weight	586.64 g/mol
Synonyms	Silodosin O-Glucuronide; Silodosin Glucuronide Metabolite; 5-[(2R)-2-[[2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydro-1H-indole-7-carboxylic acid β-D-Glucopyranosiduronic acid; Rapaflo Glucuronide Metabolite; KMD-3213G; (2R)-2-[[2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydro-1H-indole-7-carboxylic acid β-D-Glucopyranosiduronic acid
EINECS	Contact for details

Quality Control

Our Silodosin Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, LC-MS for structural confirmation, and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to guarantee traceability and 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). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. For long-term storage, consider freezing at -20°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (Mass Spectrometry)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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