Description

Silodosin Impurity 2 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Silodosin, a medication used to treat benign prostatic hyperplasia. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Silodosin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Silodosin.

Basic Information

Product Name	Silodosin Impurity 2 Hcl
CAS No.	1889255-72-4
Molecular Formula	C25H32F3N3O4 • HCl
Molecular Weight	532.00 g/mol (approx.)
Synonyms	Silodosin Related Compound 2 Hcl; Silodosin EP Impurity 2 Hcl; Silodosin USP Impurity 2 Hcl; 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide Hydrochloride; Silodosin Impurity B Hcl; Silodosin Process Impurity 2 Hcl; Desisobutyryl Silodosin Hcl
EINECS	Contact for details

Quality Control

Every batch of Silodosin Impurity 2 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, ensuring full traceability and regulatory readiness for our clients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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