Description

Sulfasalazine Impurity D 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 quality control testing. Precise characterization of such impurities is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Sulfasalazine Impurity D in drug substance and finished product analysis.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurities in Sulfasalazine batches.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to ensure Sulfasalazine API and formulations meet specified impurity limits per ICH, USP, or EP guidelines.
• Stability Studies: Used to track the formation and level of this specific degradation product during forced degradation and long-term stability studies of Sulfasalazine.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Serves as a key material in pharmaceutical R&D for studying the degradation pathways and chemistry of Sulfasalazine.

Basic Information

Product Name	Sulfasalazine Impurity D
CAS No.	66364-70-3
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-[[p-(2-Pyridylsulfamoyl)phenyl]azo]salicylic Acid; 5-({4-[(Pyridin-2-ylsulfamoyl)phenyl]diazenyl}-2-hydroxybenzoic Acid; N-(Pyridin-2-yl)-4-[(2-carboxy-4-hydroxyphenyl)diazenyl]benzenesulfonamide; Salicylazosulfapyridine Impurity D; SASP Impurity D; Sulfasalazine Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulated environments.

Storage

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

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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