Description

Olsalazine Sodium Ep Impurity B is a high-purity chemical reference standard, specifically identified as a known impurity of Olsalazine Sodium. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers involved in the development and production of Olsalazine Sodium, an anti-inflammatory prodrug.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Olsalazine Sodium Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH guidelines.
• Quality Control & Assurance: Essential for routine batch testing to monitor impurity levels and ensure the final product meets stringent pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed as a marker to track degradation pathways and assess the shelf-life of Olsalazine Sodium formulations under various storage conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Utilized in synthetic chemistry research to understand and control impurity formation during the manufacturing process of the parent drug.

Basic Information

Product Name	Olsalazine Sodium Ep Impurity B
CAS No.	752188-68-4
Molecular Formula	C14H8N2Na2O6
Molecular Weight	346.20 g/mol
Synonyms	5,5'-Azobis(2-hydroxybenzoic acid) disodium salt; Disodium 5,5'-azobis(2-hydroxybenzoate); Disodium 2,2'-(diazene-1,2-diyl)bis(5-hydroxybenzoate); Olsalazine Sodium Impurity B; Azodisal Sodium Impurity B; Sodium 5,5'-azobis(salicylate); Dipentum Impurity B
EINECS	Contact for details

Quality Control

Every batch of Olsalazine Sodium Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and impurity profile.

Storage

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

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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