Description

Silodosin Carboxylic Acid Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Silodosin by enabling the accurate identification, quantification, and control of this specific process-related impurity. It is an essential tool for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D, quality control laboratories, and regulatory affairs to meet stringent ICH guidelines for impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Silodosin API and related drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating robust analytical methods, particularly HPLC and UPLC, for impurity detection.
• Quality Control and Batch Release: Used in routine QC testing to monitor and ensure impurity levels in Silodosin batches remain within specified regulatory limits.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control strategy.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Silodosin synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Silodosin Carboxylic Acid Impurity
CAS No.	1431373-77-1
Molecular Formula	C25H32F3N3O4
Molecular Weight	495.54 g/mol
Synonyms	5-[(2R)-2-{[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl}amino]propyl]-2,3-dihydro-1H-indole-7-carboxylic Acid; Silodosin Acid Impurity; Silodosin Carboxylic Acid; Silodosin Related Compound; Uroxatral Carboxylic Acid Impurity; (R)-5-[2-[[2-(2,2,2-Trifluoroethoxy)phenoxy]ethylamino]propyl]indoline-7-carboxylic Acid; 1431373-77-1; UNII-9K5P3E3W8R
EINECS	Contact for details

Quality Control

Every batch of Silodosin Carboxylic Acid Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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