Description

Silodosin Impurity 27 is a designated pharmaceutical reference standard used in the analytical profiling and quality control of Silodosin active pharmaceutical ingredient (API). This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance 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.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports impurity isolation, characterization, and toxicological studies during the drug development process.

Basic Information

Product Name	Silodosin Impurity 27
CAS No.	1803448-63-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Silodosin Related Compound 27; Silodosin EP Impurity I; 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; UNII-9Q5F7K7F2I; 9Q5F7K7F2I; Silodosin Impurity 27 (EP); Silodosin Impurity 27 (USP)
EINECS	Contact for details

Quality Control

Every batch of Silodosin Impurity 27 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity. 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 5.0%

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