Description

Sulfasalazine Impurity F is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Sulfasalazine. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities to ensure drug safety and efficacy. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sulfasalazine Impurity F in drug substance and drug product analysis.
• Method Development and Validation: Crucial for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC testing of Sulfasalazine API and finished dosage forms to monitor impurity profiles and ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific degradation product during forced degradation and long-term stability studies of Sulfasalazine.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Research and Development: Facilitates impurity profiling and route scouting during the synthetic process development of Sulfasalazine.

Basic Information

Product Name	Sulfasalazine Impurity F
CAS No.	66364-71-4
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-[[4-[(2-Pyridinylamino)sulfonyl]phenyl]azo]salicylic acid; 5-({4-[(Pyridin-2-ylamino)sulfonyl]phenyl}diazenyl)-2-hydroxybenzoic acid; Sulfapyridine-azo-salicylic acid; SASP Impurity F; Sulfasalazine Related Compound F
EINECS	Contact for details

Quality Control

Our Sulfasalazine Impurity F is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications developed for pharmaceutical impurity standards. We support compliance with current Good Manufacturing Practices (cGMP) and ICH Q3A/B guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and analytical performance.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.