Description

Albendazole Impurity 14 CAS NO 132119-01-8 is a designated reference standard used in the pharmaceutical quality control process. This compound is critical for ensuring the purity, safety, and efficacy of the anthelmintic drug Albendazole through precise analytical methods. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in drug substance and product testing.
• Method Development and Validation: Crucial for developing, qualifying, and validating analytical methods to detect and quantify impurities in Albendazole API and formulations.
• Quality Assurance & Control (QA/QC): Used in routine batch release testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions during drug product shelf-life studies.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive characterization and control of specified impurities.
• Research and Development: Serves as a key intermediate or marker in synthetic route optimization and impurity synthesis studies for generic drug development.

Basic Information

Product Name	Albendazole Impurity 14
CAS No.	132119-01-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albendazole Related Compound; Albendazole Specified Impurity; Albendazole EP Impurity; Albendazole USP Impurity; Albendazole Degradant; Methyl [5-(propylthio)-1H-benzimidazol-2-yl]carbamate Impurity; (5-(Propylthio)-1H-benzo[d]imidazol-2-yl)carbamic acid methyl ester impurity
EINECS	Contact for details

Quality Control

Every batch of Albendazole Impurity 14 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced techniques like HPLC, NMR, and MS to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

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 to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.