Description

Albendazole Ep Impurity F is a designated impurity standard used in the pharmaceutical development and quality control of Albendazole, a widely used anthelmintic drug. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential tool for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Albendazole Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Albendazole API and formulations meet stringent pharmacopoeial specifications (e.g., EP, USP) for impurity limits.
• Stability Studies: Employed to track the formation and level of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control of impurities.
• Research & Development: Supports synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Albendazole Ep Impurity F
CAS No.	80983-45-5
Molecular Formula	C12H15N3O2S
Molecular Weight	265.33 g/mol
Synonyms	Albendazole Impurity F; Albendazole Related Compound F; 5(6)-Propylthio-1H-benzimidazol-2-amine; 5-Propylthio-1H-benzo[d]imidazol-2-amine; 6-Propylthio-1H-benzo[d]imidazol-2-amine; Albendazole EP Impurity F; Albendazole USP Related Compound F
EINECS	Contact for details

Quality Control

Our Albendazole Ep Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, MS), and residual solvent analysis to ensure compliance with pharmacopoeial standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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