Description

Mebendazole Impurity B is a specified impurity and a key reference standard used in the quality control of the anthelmintic drug Mebendazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research and development, method validation, and regulatory compliance testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Mebendazole Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine quality control testing to ensure Mebendazole meets pharmacopeial standards (e.g., USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation impurities in Mebendazole under various stability-indicating conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity profiles and control strategies.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Mebendazole.

Basic Information

Product Name	Mebendazole Impurity B
CAS No.	21472-33-3
Molecular Formula	C₁₆H₁₃N₃O₃
Molecular Weight	295.29 g/mol
Synonyms	5-Benzoyl-1H-benzimidazol-2-amine; 2-Amino-5-benzoylbenzimidazole; Mebendazole Impurity B (EP); Mebendazole Related Compound B; Mebendazole EP Impurity B; 5-Benzoyl-2-benzimidazolinamine; 2-Benzimidazolinamine, 5-benzoyl-; 5-Benzoyl-2-benzimidazolamine
EINECS	Contact for details

Quality Control

Our Mebendazole Impurity B is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR). We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and batch-specific data to support your regulatory and quality assurance needs. The material is suitable for use as a reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The compound is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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