Description

Balsalazide 3-Isomer CAS NO 1242567-09-4 is a specific isomeric form of the active pharmaceutical ingredient balsalazide, a prodrug of 5-aminosalicylic acid (5-ASA). This high-purity isomer is critical for pharmaceutical research and development, particularly in the formulation of targeted therapies for inflammatory bowel diseases. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for drug development, impurity profiling, and reference standard applications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for analytical method development, validation, and quality control of balsalazide drug substances and products.
• Impurity Profiling and Control: Essential for identifying, quantifying, and monitoring process-related impurities and degradation products in balsalazide manufacturing.
• Active Pharmaceutical Ingredient (API) Research: Serves as a key intermediate or controlled impurity in the research and development of novel balsalazide-based formulations and dosage forms.
• Metabolic and Pharmacokinetic Studies: Utilized in preclinical and clinical studies to understand the isomer-specific metabolism, stability, and bioavailability.
• Regulatory Submissions: Provides necessary data and material for regulatory filings (e.g., with FDA, EMA) to establish specification limits for isomeric purity.

Basic Information

Product Name	Balsalazide 3-Isomer
CAS No.	1242567-09-4
Molecular Formula	C17H15N3O6
Molecular Weight	357.32 g/mol
Synonyms	Balsalazide Isomer 3; 5-[[4-[[(2-Carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic acid Isomer; Balsalazide Related Compound; (E)-5-((4-((2-Carboxyethyl)carbamoyl)phenyl)diazenyl)-2-hydroxybenzoic acid (specific isomer); Balsalazide Impurity; Colazide Isomer; Giazo Isomer
EINECS	Contact for details

Quality Control

Our Balsalazide 3-Isomer is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic techniques (HPLC, UPLC) and spectroscopic methods (NMR, MS), to ensure high isomeric and chemical purity. Certificates of Analysis (COA) detailing identity, purity, and impurity profiles are provided and traceable to primary reference standards. Our quality commitment aligns with ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC, Area %)	≥ 98.0%
Isomeric Purity (HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
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.