Description

Albendazole Bp Impurity L CAS NO 108579-67-5 is a specified impurity of the anthelmintic drug Albendazole, as defined in pharmacopeial standards. This compound is critical for pharmaceutical manufacturers to ensure the quality, safety, and regulatory compliance of their active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories and quality control departments for use as a certified reference standard in method development, validation, and routine impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Albendazole Bp Impurity L in Albendazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or other chromatographic methods for impurity analysis.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., BP, USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research aimed at understanding and controlling impurity formation pathways.

Basic Information

Product Name	Albendazole Bp Impurity L
CAS No.	108579-67-5
Molecular Formula	C₁₂H₁₅N₃O₂S
Molecular Weight	265.33 g/mol
Synonyms	Albendazole Impurity L; Albendazole Related Compound L; Methyl [5-(propylthio)-1H-benzimidazol-2-yl]carbamate; 5-(Propylthio)-2-carbomethoxyaminobenzimidazole; Albendazole Sulfoxide Impurity; Albendazole EP Impurity L
EINECS	Contact for details

Quality Control

Every batch of Albendazole Bp Impurity L is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances.

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 nature, the container should be kept in a desiccated environment to prevent moisture absorption.

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 single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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