Description

Sulfasalazine Ep Impurity I is a designated impurity standard used in the pharmaceutical development and quality control of Sulfasalazine. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Sulfasalazine-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sulfasalazine API.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods.
• Quality Assurance & Control (QA/QC): Used in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products in Sulfasalazine 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: Supports impurity profiling and route scouting during the synthetic process development of Sulfasalazine.

Basic Information

Product Name	Sulfasalazine Ep Impurity I
CAS No.	1310803-27-0
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-[[4-[(2-Pyridinylamino)sulfonyl]phenyl]azo]salicylic Acid; Sulfasalazine Impurity I (EP); Sulfasalazine Related Compound I; 4-Hydroxy-4'-(2-pyridylsulfamoyl)azobenzene-3-carboxylic Acid; Sulfasalazine Degradation Product; Azopyridine Salicylate Impurity; Sulfasalazine EP Impurity A; N-(2-Pyridyl)-4-[(2-hydroxy-5-carboxyphenyl)azo]benzenesulfonamide
EINECS	Contact for details

Quality Control

Our Sulfasalazine Ep Impurity I is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized and qualified using advanced techniques including HPLC, mass spectrometry, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, ensuring compliance with relevant pharmacopeial guidelines (EP, USP) and ICH Q3B(R2) specifications.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Orange to red powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.