Description

Albendazole Impurity 13 is a designated reference standard used in the analytical profiling and quality control of the anthelmintic drug Albendazole. This high-purity chemical is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Albendazole Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling in compliance with ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to monitor impurity formation in Albendazole under various stress conditions.
• Research & Development: Utilized in synthetic chemistry R&D to study the degradation pathways and metabolism of Albendazole.

Basic Information

Product Name	Albendazole Impurity 13
CAS No.	140240-75-1
Molecular Formula	C12H15N3O2S
Molecular Weight	265.33 g/mol
Synonyms	Albendazole Impurity J; Albendazole Related Compound J; 5-(Propylthio)-1H-benzimidazol-2-amine; 5-Propylsulfanyl-1H-benzoimidazol-2-ylamine; Albendazole EP Impurity J; Albendazole USP Related Compound J; Albendazole Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Albendazole Impurity 13 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with pharmacopeial standards (USP, EP) and customer-specific requirements. 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). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.