Description

Silodosin Impurity CAS NO 1638212-09-5 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. It is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Silodosin. This impurity standard is essential for analytical method development, validation, and routine quality control testing. Pharmaceutical manufacturers and analytical laboratories rely on this standard to identify, quantify, and control this specific impurity, thereby guaranteeing the efficacy and purity of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Silodosin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Silodosin products meet stringent pharmacopeial (e.g., USP, EP, JP) and ICH guidelines for impurity profiles.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control over the manufacturing process.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways by identifying and minimizing the formation of this specific impurity during Silodosin production.

Basic Information

Product Name	Silodosin Impurity
CAS No.	1638212-09-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Silodosin Related Compound; Silodosin Process Impurity; Silodosin Degradant; (R)-5-[2-[[2-(2,2,2-Trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2-methoxybenzenesulfonamide Impurity; UNII-9FQ6S4A4K4 Impurity; 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide Impurity; KMD-3213 Impurity
EINECS	Contact for details

Quality Control

Every batch of Silodosin Impurity (CAS 1638212-09-5) is manufactured and tested under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP and regulatory environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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