Description

Docusate Sodium Impurity CAS NO 86878-53-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Docusate Sodium. It is primarily required by pharmaceutical manufacturers and quality control laboratories for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Docusate Sodium drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, GC, or other chromatographic methods for purity analysis.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC labs to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity control strategies.
• Stability Studies: Employed to track the formation of degradation products in Docusate Sodium formulations under various storage conditions.
• Research and Development (R&D): Used in pharmaceutical R&D to study the synthesis pathways, degradation mechanisms, and metabolic profiles related to Docusate Sodium.

Basic Information

Item	Detail
Product Name	Docusate Sodium Impurity
CAS No.	86878-53-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Docusate Sodium Related Compound; Dioctyl Sulfosuccinate Sodium Salt Impurity; DSS Impurity; 1,4-Bis(2-ethylhexyl) sulfobutanedioate sodium salt impurity; Aerosol OT Impurity; Colace Impurity; DOSS Impurity; Sodium Dioctyl Sulfosuccinate Impurity
EINECS	Contact for details

Quality Control

Our Docusate Sodium Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, ensuring traceability and compliance with ICH guidelines for impurities in new drug substances. Certificates are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual limits
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.