Description

Albendazole Impurity 15 is a designated reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Albendazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The precise characterization of this impurity is essential for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Albendazole API and its formulations.
• Analytical Method Development: Used in the development and validation of HPLC, UPLC, and other chromatographic methods for impurity detection and quantification.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require full impurity characterization.
• Stability Studies: Employed as a marker to monitor impurity formation in Albendazole drug products under various stability conditions.
• Research & Development: Utilized in pharmacokinetic, metabolic, and toxicological studies to understand the profile of Albendazole-related substances.
• Pharmacopoeial Testing: Supports testing procedures aligned with compendial standards such as USP, EP, or BP for Albendazole.

Basic Information

Product Name	Albendazole Impurity 15
CAS No.	1805694-08-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albendazole Related Compound 15; Albendazole EP Impurity I; Albendazole USP Impurity; Albendazole Process Impurity; Methyl 5-(propylthio)-1H-benzoimidazol-2-ylcarbamate Impurity; 5-(Propylthio)-2-carbamoylbenzimidazole Derivative
EINECS	Contact for details

Quality Control

Every batch of Albendazole Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity and structural confirmation data, is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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