Description

Albendazole Impurity M is a designated impurity of the broad-spectrum anthelmintic drug Albendazole. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, purification, and analysis of Albendazole and its related substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Albendazole Impurity M in drug substances and finished products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the drug manufacturing process.
• Stability Studies: Employed in forced degradation and long-term stability studies of Albendazole to understand its degradation pathways and ensure product shelf-life.
• Quality Assurance & Control (QA/QC): A critical component for establishing specification limits and ensuring batch-to-batch consistency in compliance with ICH, USP, and EP guidelines.
• Regulatory Submissions: Required for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research on Metabolism and Degradation: Used in studies to investigate the metabolic pathways and environmental degradation products of Albendazole.

Basic Information

Product Name	Albendazole Impurity M
CAS No.	164801-24-5
Molecular Formula	C₁₂H₁₅N₃O₂S
Molecular Weight	265.33 g/mol
Synonyms	Albendazole Impurity 4; Albendazole Related Compound M; 5-(Propylthio)-1H-benzimidazol-2-amine; 5-Propylsulfanyl-1H-benzoimidazol-2-ylamine; Albendazole EP Impurity M; Albendazole USP Impurity M; Albendazole Sulfoxide Impurity; 2-Amino-5-(propylthio)benzimidazole
EINECS	Contact for details

Quality Control

Every batch of Albendazole Impurity M is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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