Description

Sulfasalazine Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Sulfasalazine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining drug efficacy and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Sulfasalazine API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately detect and quantify impurities.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in drug products.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and metabolism of Sulfasalazine.
• Pharmacopeial Testing: Serves as a system suitability standard for tests prescribed in USP, EP, or other pharmacopeias.

Basic Information

Product Name	Sulfasalazine Impurity 4
CAS No.	2033064-46-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sulfasalazine Related Compound 4; Sulfasalazine Impurity D; Sulfasalazine EP Impurity D; Sulfasalazine USP Impurity; 5-[[4-[(2-Pyridinylamino)sulfonyl]phenyl]azo]salicylic acid Impurity; Azulfidine Impurity 4; Salazosulfapyridine Impurity 4
EINECS	Contact for details

Quality Control

Our Sulfasalazine Impurity 4 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 (store away from light).

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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