Description

Silodosin Impurity 37 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Silodosin through rigorous impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance testing in drug production.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Silodosin API.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical R&D and QC laboratories.
• Supports regulatory compliance and filing (e.g., for ICH guidelines Q3A(R2) and Q3B(R2)) by providing a characterized impurity for submission dossiers.
• Used in stability studies to monitor impurity formation in Silodosin drug products under various storage conditions.
• Critical for pharmacopoeial testing to ensure Silodosin batches meet USP/EP monograph specifications.
• Facilitates process chemistry research to understand and minimize impurity formation during Silodosin synthesis.

Basic Information

Product Name	Silodosin Impurity 37
CAS No.	885340-14-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Silodosin Related Compound 37; Silodosin EP Impurity G; Silodosin USP Impurity; 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide; (R)-1-(3-Hydroxypropyl)-5-[2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]indoline-7-carboxamide; UNII-4K7V8VK2R0
EINECS	Contact for details

Quality Control

Every batch of Silodosin Impurity 37 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C

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