Description

Sulfasalazine Ep Impurity G is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for Sulfasalazine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sulfasalazine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity profiles required by the FDA, EMA, and other global health authorities.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Sulfasalazine formulations.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways and metabolism of Sulfasalazine.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard in routine batch release testing of Sulfasalazine.

Basic Information

Product Name	Sulfasalazine Ep Impurity G
CAS No.	1391062-37-5
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-((4-((2-Pyridinylamino)sulfonyl)phenyl)azo)salicylic Acid; Sulfasalazine Impurity G; Sulfasalazine Related Compound G; Sulfasalazine EP Impurity G; 5-[[p-(2-Pyridylsulfamoyl)phenyl]azo]salicylic Acid; Azulfidine Impurity G; Salazosulfapyridine Impurity G
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and MS to ensure compliance with pharmacopeial standards (EP, USP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 maintain stability.

Specification

Item	Specification
Appearance	Yellow to Orange Powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to Reference Spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual Impurity: ≤ 0.5% Total Impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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