Description

Di-Destriazole Desmethyl Anastrozole Dimer Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the breast cancer drug anastrozole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on ensuring drug purity, stability, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of dimer-related impurities in Anastrozole Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor process-related impurities.
• Stability Studies: Employed in forced degradation and long-term stability studies of Anastrozole to understand degradation pathways and establish shelf-life.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in GMP environments to ensure impurity profiles meet ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and compliance.
• Research & Development: Used in synthetic chemistry research to study impurity formation mechanisms and to develop purification processes for the API.

Basic Information

Product Name	Di-Destriazole Desmethyl Anastrozole Dimer Impurity
CAS No.	1346604-73-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Anastrozole Dimer Impurity; Anastrozole Dimer; Desmethyl Anastrozole Dimer; Arimidex Dimer Impurity; 1,3-Bis(1-cyano-1-methylethyl)-5-[(1H-1,2,4-triazol-1-yl)methyl]benzene (related structure); Dimer Impurity of Anastrozole; Process Impurity of Anastrozole
EINECS	Contact for details

Quality Control

Our Di-Destriazole Desmethyl Anastrozole Dimer Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH Q3A, Q3B, and cGMP guidelines.

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 at 2-8°C. Handle the material under an inert atmosphere if specified to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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