Description

Albendazole Ep Impurity J is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anthelmintic drug Albendazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Albendazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and Common Technical Documents (CTDs).
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in drug products.
• Research & Development: Used in R&D for studying the degradation pathways and metabolism of Albendazole.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product purity meets pharmacopeial specifications (e.g., EP, USP).

Basic Information

Product Name	Albendazole Ep Impurity J
CAS No.	946498-41-5
Molecular Formula	C₁₂H₁₅N₃O₂S
Molecular Weight	265.33 g/mol
Synonyms	Albendazole Impurity J; Albendazole EP Impurity J; Methyl [5-(propylthio)-1H-benzimidazol-2-yl]carbamate; (5-(Propylthio)-1H-benzo[d]imidazol-2-yl)carbamic acid methyl ester; Albendazole Related Compound J; Albendazole Sulfoxide Impurity (by structure); Albendazole Metabolite Reference Standard
EINECS	Contact for details

Quality Control

Every batch of Albendazole Ep Impurity J is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure compliance with pharmacopeial standards. 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 in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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