Description

Balsalazide Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Balsalazide Disodium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality control testing of Balsalazide-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Balsalazide Disodium API and its formulations.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and product purity meets pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Balsalazide.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing characterized impurity profiles for new drug applications.
• Research & Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the API.

Basic Information

Product Name	Balsalazide Impurity 1
CAS No.	1242567-12-9
Molecular Formula	C17H15N3O6
Molecular Weight	357.32 g/mol
Synonyms	5-[[4-[(2-Carboxyethyl)carbamoyl]phenyl]azo]-2-hydroxybenzoic Acid; Balsalazide Related Compound A; Balsalazide Impurity A; Balsalazide Disodium Impurity 1; 4-[[(2-Carboxyethyl)amino]carbonyl]phenyl]azo]salicylic Acid; Azodisalicylic Acid Derivative; Balsalazide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Balsalazide Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure it meets the highest standards for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 absorption of water vapor. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	Yellow to Orange Powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.