Description

Mebendazole Impurity G is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for pharmaceutical quality control, serving as a specified impurity in the development and validation of analytical methods for the anthelmintic drug Mebendazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Mebendazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity profiles and ensure product specifications are met.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of Mebendazole.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways, metabolism, and impurity synthesis of Mebendazole.

Basic Information

Product Name	Mebendazole Impurity G
CAS No.	129165-82-8
Molecular Formula	C₁₆H₁₃N₃O₃
Molecular Weight	295.29 g/mol
Synonyms	5-Benzoyl-2-benzimidazolecarbamic Acid Methyl Ester; Mebendazole Related Compound G; (5-Benzoyl-1H-benzimidazol-2-yl)carbamic Acid Methyl Ester; Mebendazole EP Impurity G; Mebendazole USP Impurity G; Mebendazole Impurity 7; 5-Benzoyl-1H-benzimidazole-2-carbamic Acid Methyl Ester
EINECS	Contact for details

Quality Control

Every batch of Mebendazole Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with pharmacopeial standards and customer specifications. 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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