Description

Sulfasalazine Impurity 16 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Sulfasalazine by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of Sulfasalazine-based medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Sulfasalazine API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component in developing, calibrating, and validating chromatographic methods for purity analysis.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Sulfasalazine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Facilitates studies on the metabolism, degradation pathways, and chemical behavior of Sulfasalazine.

Basic Information

Product Name	Sulfasalazine Impurity 16
CAS No.	413583-25-2
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-((4-((2-Pyridinylamino)sulfonyl)phenyl)azo)salicylic acid; Sulfapyridine Azo Salicylic Acid; Sulfasalazine Related Compound 16; Sulfasalazine Degradant; Azodisal Sodium Impurity; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with industry and research-grade standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to Orange Powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
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.