Description

Silodosin-D4 is a deuterated isotopologue of the selective α-1A adrenergic receptor antagonist Silodosin, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is an essential internal standard for the accurate quantification of Silodosin in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical tool for pharmaceutical research and development, clinical pharmacology, and bioanalytical laboratories focused on drug metabolism and pharmacokinetic (DMPK) studies. The product is supplied with a high level of chemical and isotopic purity to ensure reliable and reproducible analytical results.

Application

• Bioanalytical Internal Standard: Primary use as a stable isotope-labeled internal standard for the precise quantification of Silodosin in plasma, serum, and urine via LC-MS/MS.
• Drug Metabolism Studies: Enables tracking and quantification of parent drug and metabolites in Absorption, Distribution, Metabolism, and Excretion (ADME) research.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling: Supports accurate PK profiling in preclinical and clinical trials for the development of Silodosin-based therapies.
• Forensic and Clinical Toxicology: Used in confirmatory testing and method development for the detection of Silodosin in forensic and clinical settings.
• Method Development and Validation: Critical for developing, optimizing, and validating robust bioanalytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Can be employed in impurity profiling and assay development for Silodosin active pharmaceutical ingredient (API).

Basic Information

Product Name	Silodosin-D4
CAS No.	1426173-86-5
Molecular Formula	C25H28D4F3N3O4
Molecular Weight	495.55 g/mol (approx.)
Synonyms	Silodosin-d4; 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide-d4; KMD-3213-d4; (R)-Silodosin-d4; Urief-d4; 8-Y-0001-d4; Rapaflo-d4; Isotopically Labeled Silodosin
EINECS	Contact for details

Quality Control

Every batch of Silodosin-D4 is manufactured and analyzed under strict quality systems to ensure it meets the exacting standards required for use as a quantitative internal standard. Our products undergo rigorous quality testing, including determination of chemical purity, isotopic purity (enrichment), and absence of interfering impurities. Comprehensive Certificates of Analysis (COA) are provided, detailing results from HPLC, NMR, and MS analyses. We support compliance with GMP/GLP principles for research use.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and under inert atmosphere to maintain stability and isotopic integrity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC-MS)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Enrichment)	≥ 98.0 atom % D
Chemical Purity (by NMR)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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