Description

Balsalazide Usp Rc A is a high-purity pharmaceutical reference standard and active pharmaceutical ingredient (API) used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical formulations, particularly in the development and quality control of anti-inflammatory medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, regulatory compliance testing, and advanced chemical synthesis.

Application

• Pharmaceutical Reference Standard: Used as a primary standard in HPLC, LC-MS, and other chromatographic methods for the quantitative and qualitative analysis of drug substances and products.
• Active Pharmaceutical Ingredient (API) R&D: Serves as a key starting material or intermediate in the research and development of novel pharmaceutical compounds, particularly for gastrointestinal therapies.
• Quality Control & Assurance: Essential for in-process testing, finished product release, and stability studies to verify identity, potency, and purity against established pharmacopeial monographs.
• Method Development and Validation: Employed by analytical laboratories to develop, optimize, and validate compendial and non-compendial test methods.
• Regulatory Submissions: Provides certified material for use in studies supporting regulatory filings with agencies such as the FDA, EMA, and other global health authorities.
• Academic and Clinical Research: Used in university and institutional research to study pharmacological properties, metabolic pathways, and therapeutic mechanisms of action.

Basic Information

Product Name	Balsalazide Usp Rc A
CAS No.	1398634-47-3
Molecular Formula	C17H15N3O6
Molecular Weight	357.32 g/mol
Synonyms	Balsalazide; Balsalazide Disodium; 5-[[(2-Carboxyethyl)amino]carbonyl]-2-hydroxybenzoic acid 4-[(2-Carboxyethyl)azo]phenyl ester; 5-[[4-[(2-Carboxyethyl)azo]benzoyl]amino]-2-hydroxybenzoic acid; Colazide; Giazo; Balsalazide USP Reference Standard
EINECS	Contact for details

Quality Control

Our Balsalazide Usp Rc A is manufactured and tested to meet stringent pharmacopeial standards, including USP monograph requirements. Every batch undergoes comprehensive analytical testing for identity, assay, purity, and specified impurities. A Certificate of Analysis (COA) is provided with each shipment, detailing the results against established specifications to ensure full traceability and compliance for your regulatory and research needs.

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 must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with USP/ICH guidelines
Heavy Metals	≤ 20 ppm

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