Description

Sulfasalazine Ep Impurity E is a high-purity reference standard critical for pharmaceutical analysis and quality control. This compound serves as a specified impurity in the pharmacopeial evaluation of Sulfasalazine, an important anti-inflammatory and immunosuppressive drug. It is essential for analytical laboratories, quality assurance departments, and R&D teams in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The precise characterization of this impurity is fundamental for method validation and stability studies.

Application

• Primary use as a pharmacopeial reference standard (EP/JP/USP) for Sulfasalazine impurity profiling.
• Analytical method development and validation in pharmaceutical quality control laboratories.
• Calibration and system suitability testing for HPLC, UPLC, and LC-MS methods.
• Identification and quantification of impurities in Sulfasalazine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Supporting regulatory filings (e.g., ANDA, NDA) by providing impurity identity and qualification data.
• Use in stability studies to monitor degradation pathways of Sulfasalazine.
• Research and development of impurity synthesis pathways and control strategies.

Basic Information

Product Name	Sulfasalazine Ep Impurity E
CAS No.	1391062-34-2
Molecular Formula	C18H14N4O5S
Molecular Weight	398.39 g/mol
Synonyms	5-[[4-[(2-Pyridinylamino)sulfonyl]phenyl]azo]salicylic Acid; 4-Hydroxy-4'-(2-pyridylaminosulfonyl)azobenzene-2-carboxylic Acid; Sulfasalazine Impurity E; Sulfasalazine Related Compound E; Azulfidine Impurity E; Salazosulfapyridine Impurity E; EP Impurity E of Sulfasalazine; Salicylazosulfapyridine Impurity E
EINECS	Contact for details

Quality Control

Every batch of Sulfasalazine Ep Impurity E is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to meet the stringent requirements for pharmaceutical reference standards, including identity confirmation, purity assay, and related substance analysis by HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with cGMP principles to ensure consistency and reliability for your critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

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 unspecified impurity ≤ 0.5%
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.