Description

Silodosin Carboxylic Acid Impurity is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient Silodosin, ensuring drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and regulatory compliance. Utilizing this well-characterized impurity is essential for meeting stringent pharmacopeial standards and regulatory submission requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Silodosin drug substance and finished products.
• Method Development and Validation: Used in developing and validating robust HPLC, UPLC, or GC analytical methods for impurity profiling.
• Stability Studies: Employed to monitor the formation and level of this specific degradant in Silodosin formulations under various stress conditions.
• Quality Control (QC) Testing: Essential for in-process control and release testing of Silodosin batches to ensure impurity levels are within specified limits.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to synthesize higher-purity batches of the API.

Basic Information

Product Name	Silodosin Carboxylic Acid Impurity
CAS No.	1357252-79-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Silodosin Acid Impurity; Silodosin Related Compound; Silodosin Carboxylic Acid; 5-[2-[(2R)-2-Hydroxy-2-(2,2,2-trifluoroethoxy)ethylamino]propyl]-2-methoxybenzene-1-sulfonamide carboxylic acid derivative; Silodosin Degradant; Silodosin Process Impurity; Rapaflo Impurity; Urief Impurity
EINECS	Contact for details

Quality Control

Our Silodosin Carboxylic Acid Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Contact for details
Residual Solvents (GC)	Meets ICH guidelines
Water Content (KF)	Contact for details

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