Description

Anastrozole-D3 Dimer Impurity is a deuterated, dimeric impurity of the aromatase inhibitor anastrozole, specifically used as a certified reference material for analytical purposes. This compound is critical for ensuring the accuracy and reliability of pharmaceutical testing, particularly in the development and quality control of anastrozole-based drug products. It is an essential standard for laboratories in the pharmaceutical and analytical chemistry sectors requiring precise quantification of process-related impurities.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the validation of analytical methods (e.g., HPLC, LC-MS) used in drug substance and drug product testing.
• Method Development and Validation: Used to develop, optimize, and validate stability-indicating methods for the accurate detection and quantification of dimeric impurities in anastrozole.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to monitor and control impurity profiles during the manufacturing process of anastrozole API and finished dosage forms.
• Regulatory Compliance & Filing: Essential for generating impurity data to support regulatory submissions (e.g., to FDA, EMA) and to comply with ICH guidelines (Q3A, Q3B) on impurities.
• Stability Studies: Used as a marker to track the formation of degradation products in forced degradation and long-term stability studies of anastrozole formulations.
• Research & Development: Critical for impurity profiling, identification, and characterization studies during the synthetic route development and process optimization of anastrozole.

Basic Information

Item	Detail
Product Name	Anastrozole-D3 Dimer Impurity
CAS No.	1329809-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Deuterated Anastrozole Dimer; Anastrozole-d3 Dimer; Anastrozole Dimer-d3; 2,2'-[5-((1H-1,2,4-Triazol-1-yl)methyl)-1,3-phenylene]bis(2-methylpropane-3,3,3-d3-nitrile) (IUPAC-based); Arimidex Impurity Dimer-d3; Anastrozole Deuterated Dimer Impurity; Anastrozole Related Compound Dimer-d3
EINECS	Contact for details

Quality Control

Every batch of Anastrozole-D3 Dimer Impurity is manufactured and analyzed under strict quality systems. It undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as NMR, HPLC, and mass spectrometry to ensure it meets the high standards required for a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, and confirming compliance with relevant pharmacopeial and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Deuteration Degree (MS)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
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.