Description

Olsalazine Sodium Ep Impurity C is a high-purity chemical reference standard, specifically identified as an impurity of Olsalazine Sodium. This compound is critical for analytical research and quality control processes in the pharmaceutical industry, ensuring the safety and efficacy of the final drug product. It is primarily used by researchers, analytical laboratories, and quality assurance departments involved in the development and manufacturing of pharmaceuticals, particularly those related to anti-inflammatory medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Olsalazine Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (EP, USP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Olsalazine Sodium.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies such as the FDA and EMA.
• Research & Development: Used in synthetic chemistry and pharmaceutical R&D to study the chemical behavior, synthesis pathways, and purification processes of related compounds.

Basic Information

Product Name	Olsalazine Sodium Ep Impurity C
CAS No.	259151-72-9
Molecular Formula	C14H8N2Na2O6
Molecular Weight	346.20 g/mol
Synonyms	5-[(E)-2-Carboxyethenyl]azobenzene-2-carboxylic acid disodium salt; Disodium 5,5'-[(E)-diazene-1,2-diyl]bis(2-hydroxybenzoate); Azodisalicylate disodium salt impurity; Olsalazine disodium impurity C; Dipotassium azodisalicylate impurity (related); Azodisal sodium impurity; ADS impurity C
EINECS	Contact for details

Quality Control

Our Olsalazine Sodium Ep Impurity C is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current industry best practices for reference standards. Certificates of Analysis (COA) are provided, detailing results from tests such as HPLC purity, NMR, and mass spectrometry for full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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