Description

Sulfasalazine Ep Impurity B is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient Sulfasalazine. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in method validation and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in Sulfasalazine API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods in compliance with ICH guidelines.
• Quality Control and Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring product consistency and regulatory compliance.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Standards: Can be used as a working standard for testing against monographs in the USP, EP, BP, or other international pharmacopoeias.

Basic Information

Product Name	Sulfasalazine Ep Impurity B
CAS No.	1391062-49-9
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-((4-((Pyridin-2-yl)sulfamoyl)phenyl)diazenyl)salicylic acid; Sulfasalazine Impurity B; Sulfasalazine Related Compound B; Ep Impurity B of Sulfasalazine; AZULFIDINE Impurity B; Salazosulfapyridine Impurity B
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

Storage

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

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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