Description

Silodosin Impurity 21 is a designated pharmaceutical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Silodosin. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Silodosin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Silodosin Impurity 21
CAS No.	1025922-97-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Silodosin Related Compound 21; Silodosin EP Impurity J; 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; Silodosin Impurity J; Silodosin Process Impurity; Silodosin Degradant
EINECS	Contact for details

Quality Control

Our Silodosin Impurity 21 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material in accordance with good laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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