Description

Di-Destriazole Anastrozole Dimer Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of dimeric impurities during the synthesis and quality assurance of Anastrozole, a potent aromatase inhibitor. It is primarily required by analytical chemists, quality control laboratories, and regulatory affairs professionals within the global pharmaceutical and fine chemical industries to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of the dimer impurity in Anastrozole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods for Anastrozole.
• Quality Control & Release Testing: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate comprehensive control of the manufacturing process.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Anastrozole synthesis pathway to minimize the formation of this dimeric by-product.

Basic Information

Product Name	Di-Destriazole Anastrozole Dimer Impurity
CAS No.	918312-71-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Anastrozole Dimer Impurity; Anastrozole Dimer; Di-Destriazole Anastrozole Dimer; Anastrozole Related Compound Dimer; 1,3-Bis(1H-1,2,4-triazol-1-ylmethyl)-5-[(1-cyanocyclopentyl)methyl]-5-methyl-2,4-imidazolidinedione (tentative); Arimidex Dimer Impurity; Anastrozole Impurity D; ZD1033 Dimer Impurity
EINECS	Contact for details

Quality Control

Every batch of Di-Destriazole Anastrozole Dimer Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

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

Specification

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