Description

Silodosin β-D-Glucuronide Sodium Salt is a high-purity, pharmacologically relevant metabolite and reference standard. This compound is critical for analytical research and development, particularly in the fields of bioanalysis and drug metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method validation, pharmacokinetic profiling, and ensuring regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of Silodosin and its metabolites in various matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and excretion profiles of Silodosin.
• Bioanalytical Method Development & Validation: Serves as a critical component in developing and validating robust HPLC, LC-MS, or LC-MS/MS methods for clinical and preclinical samples.
• Impurity Profiling and Characterization: Employed to identify, quantify, and monitor process-related impurities and degradation products in active pharmaceutical ingredient (API) batches.
• Clinical Research: Used in studies to understand patient-specific metabolic variations and to support regulatory submissions for drug approval.
• Quality Control & Assurance: Ensures batch-to-batch consistency and compliance with stringent pharmacopoeial standards (e.g., USP, EP) in pharmaceutical manufacturing.

Basic Information

Product Name	Silodosin β-D-Glucuronide Sodium Salt
CAS No.	879292-24-7
Molecular Formula	C32H47FN2O9•Na
Molecular Weight	645.73 g/mol
Synonyms	Silodosin Glucuronide Sodium Salt; Silodosin β-D-Glucopyranosiduronic Acid Sodium Salt; Silodosin N-Glucuronide Sodium Salt; (R)-5-[2-[[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydro-1H-indole-7-carboxylic Acid β-D-Glucuronide Sodium Salt; Silodosin Metabolite Sodium Salt; Silodosin-β-D-Glucuronide Na; KMD-3213G Na; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Silodosin β-D-Glucuronide Sodium Salt is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure high chemical purity and structural identity, meeting the exacting standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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