Description

Docusate Sodium Impurity A CAS NO 115960-17-3 is a high-purity reference standard used for the identification and quantification of a key process-related impurity in Docusate Sodium, a widely used pharmaceutical excipient. This compound is critical for ensuring the quality, safety, and regulatory compliance of finished drug products, particularly in laxative formulations. It is an essential material for pharmaceutical R&D, quality control laboratories, and manufacturers requiring rigorous impurity profiling to meet pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development, validation, and routine quality control testing of Docusate Sodium API and drug products.
• Impurity Profiling and Control: Critical for identifying, monitoring, and controlling the levels of this specific impurity during API synthesis and formulation to ensure product safety and efficacy.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive characterization data for impurity identification as required by ICH Q3A and Q3B guidelines.
• Stability Studies: Used as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Method Transfer and Verification: Serves as a system suitability standard when transferring analytical methods between laboratories or sites.
• Research and Development: Utilized in process chemistry R&D to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Docusate Sodium Impurity A
CAS No.	115960-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dioctyl Sulfosuccinate Sodium Salt Impurity A; DSS Impurity A; 1,4-Bis(2-ethylhexyl) sulfobutanedioate sodium salt related compound A; Aerosol OT Impurity A; Docusate Impurity A; Sodium 1,4-bis(2-ethylhexyl) sulfosuccinate Impurity A
EINECS	Contact for details

Quality Control

Every batch of Docusate Sodium Impurity A is manufactured and analyzed under strict quality management systems. The material is characterized using advanced analytical techniques including HPLC, GC, and NMR to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Related Substances (HPLC)	Meets internal specifications
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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