Description

Anastrozole Dimer Impurity is a high-purity reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Anastrozole. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, quality control laboratories, and API manufacturers involved in the development and production of aromatase inhibitor therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Anastrozole API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately identify and quantify the dimer impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation impurities in Anastrozole under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Anastrozole to minimize the formation of this specific dimer.

Basic Information

Item	Detail
Product Name	Anastrozole Dimer Impurity
CAS No.	1216898-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Anastrozole Dimer; Anastrozole Related Compound Dimer; Bis-anastrozole Impurity; 2,2'-[5-[(1H-1,2,4-Triazol-1-yl)methyl]-1,3-phenylene]bis(2-methyl-3-phenylpropiononitrile); Arimidex Dimer Impurity; 1,3-Bis[α,α-dimethyl-α-(4-cyanophenyl)methyl]-5-(1H-1,2,4-triazol-1-ylmethyl)benzene
EINECS	Contact for details

Quality Control

Every batch of our Anastrozole Dimer Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing using advanced techniques like HPLC and LC-MS to confirm identity, purity, and strength. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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