Description

Sulfasalazine Ep Impurity A is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Sulfasalazine by serving as a key marker for impurity profiling. It is an essential material for pharmaceutical quality control laboratories, R&D facilities, and regulatory bodies involved in method development and validation. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards for drug substance manufacturing.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Sulfasalazine API.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for pharmaceutical quality control.
• Used in stability studies and forced degradation studies to monitor impurity formation in drug products.
• Essential for regulatory compliance and filing, supporting documentation for FDA, EMA, and other health authority submissions.
• Valuable research tool in pharmacology and metabolic studies to understand drug degradation pathways.
• Serves as a system suitability standard in pharmaceutical laboratory testing to ensure analytical instrument performance.

Basic Information

Product Name	Sulfasalazine Ep Impurity A
CAS No.	1391062-35-3
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-((E)-((4-((Pyridin-2-yl)sulfamoyl)phenyl)diazenyl)salicylic Acid; Sulfasalazine Impurity A; Sulfasalazine Related Compound A; Sulfasalazine EP Impurity A; Azulfidine Impurity A; Salazosulfapyridine Impurity A; 2-Hydroxy-5-[(E)-2-{4-[(pyridin-2-ylamino)sulfonyl]phenyl}diazen-1-yl]benzoic Acid
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine Ep Impurity A is manufactured and analyzed under strict quality management systems. The material is characterized and qualified using advanced spectroscopic and chromatographic techniques, including NMR, Mass Spectrometry, and HPLC, to ensure structural identity and high chemical purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH Q3A, Q3B, EP, and USP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Red to brown powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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